Sample records for a-007 topical gel

  1. A novel lidocaine hydrochloride ophthalmic gel for topical ocular anesthesia

    PubMed Central

    Shah, HR; Reichel, E; Busbee, BG

    2010-01-01

    Topical anesthetics play an important role in the practice of ophthalmology, both for procedures in the office and in the operating room. The need for safe, long-acting topical ocular anesthetic agents is ongoing, and has been highlighted by the increase of intravitreal administration of pharmacologic agents. Current practices for ocular anesthesia include subconjunctival injection of 2% aqueous lidocaine, topical 2% lidocaine drops and topical 0.5% tetracaine. Tetracaine is not yet FDA approved, and is associated with corneal epithelial toxicity and delayed epithelial healing after multiple administrations. Lidocaine jelly (2%) preparations have been reported to be beneficial in several systemic procedures, including those of the upper airway, dental, urogenital, and gastrointestinal. It has been theorized, and recent studies support the idea, that gel formulations of lidocaine may enhance anesthetic effect, and therefore be superior to anesthetic solutions for topical cataract surgery. The viscous nature of gel formulations is thought to lengthen contact time, resulting in better anesthesia at lower drug concentrations. Furthermore, several studies suggest that lidocaine is bactericidal and bacteriostatic, and may have a supplementary role in preventing and treating surgical site infections. Akten™, lidocaine 3.5% gel (Akorn, Buffalo Grove, IIlinois) was FDA approved for all ophthalmic procedures in October 2008. This gel is a preservative-free, lidocaine-based anesthetic gel consisting of 35 mg/mL of lidocaine hydrochloride. We describe the properties, including chemical structure, indications, evidence of support, use, adverse effects, and precautions, which we believe enable Akten to provide superior anesthesia, while minimizing side effects. PMID:22915870

  2. A comparison of a refrigerant and a topical anesthetic gel as preinjection anesthetics: a clinical evaluation.

    PubMed

    Kosaraju, Amar; Vandewalle, Kraig S

    2009-01-01

    The authors used a split-mouth design to determine the effectiveness of a refrigerant compared with that of a topical anesthetic gel in reducing the pain experienced during a posterior palatal anesthetic injection. Sixteen participants received a five-second application of a refrigerant (1,1,1,3,3-pentafluoropropane/1,1,1,2-tetrafluoroethane) and a two-minute application of a topical anesthetic gel (20 percent benzocaine gel) in the posterior palatal area before an injection of a local anesthetic solution was administered with a 30-gauge needle. Participants rated the pain they experienced after each injection by using a 100-millimeter visual analog scale (VAS) with endpoints of "no pain" and "worst possible pain." The authors calculated VAS scores by measuring the distance in millimeters from the no pain end of the scale. They analyzed data with a paired t test (alpha = .05). The group receiving the refrigerant had a mean VAS score of 17.7 +/- 15.3 mm, and the group receiving the topical anesthetic gel had a VAS score of 26.2 +/- 18.0 mm. The use of the refrigerant compared with the use of topical anesthetic gel significantly reduced the pain experienced during administration of local anesthetic injections (P = .02). The use of a refrigerant as a preinjection anesthetic was more effective compared with the use of a topical anesthetic gel in reducing the pain experienced by participants who received a posterior palatal injection. The potential benefits of using a refrigerant rather than a topical anesthetic gel are pain reduction, decreased application time, ease of application and avoidance of displeasing taste.

  3. Prevention of postsurgical scars: comparsion of efficacy and convenience between silicone gel sheet and topical silicone gel.

    PubMed

    Kim, Sue-Min; Choi, Jung-Sik; Lee, Jung-Ho; Kim, Young-Jin; Jun, Young-Joon

    2014-11-01

    To date, few studies have compared the effectiveness of topical silicone gels versus that of silicone gel sheets in preventing scars. In this prospective study, we compared the efficacy and the convenience of use of the 2 products. We enrolled 30 patients who had undergone a surgical procedure 2 weeks to 3 months before joining the study. These participants were randomly assigned to 2 treatment arms: one for treatment with a silicone gel sheet, and the other for treatment with a topical silicone gel. Vancouver Scar Scale (VSS) scores were obtained for all patients; in addition, participants completed scoring patient questionnaires 1 and 3 months after treatment onset. Our results reveal not only that no significant difference in efficacy exists between the 2 products but also that topical silicone gels are more convenient to use. While previous studies have advocated for silicone gel sheets as first-line therapies in postoperative scar management, we maintain that similar effects can be expected with topical silicone gel. The authors recommend that, when clinicians have a choice of silicone-based products for scar prevention, they should focus on each patient's scar location, lifestyle, and willingness to undergo scar prevention treatment.

  4. A Randomized Male Tolerance Study of Dapivirine Gel Following Multiple Topical Penile Exposures (MTN 012/IPM 010)

    PubMed Central

    Hoesley, Craig; Carballo-Diéguez, Alex; Hendrix, Craig W.; Husnik, Marla; Levy, Lisa; Hall, Wayne; Soto-Torres, Lydia; Nel, Annalene M.

    2014-01-01

    Abstract Dapivirine (DPV) is a nonnucleoside reverse transcriptase inhibitor with a favorable safety profile following vaginal application. A penile tolerance study was conducted prior to further development of DPV as a candidate vaginal microbicide. Twenty-four circumcised and 24 uncircumcised (N=48) healthy HIV-negative male participants aged 18 years or older were randomized 2:1:1 to apply DPV 0.05% gel, matched placebo gel, or universal placebo gel, respectively, to their penis once daily for 7 sequential days. The safety, acceptability, and pharmacokinetic profile of DPV 0.05% gel were assessed by the presence of Grade 2 or higher genitourinary adverse events (AEs) and systemic AEs, a behavioral questionnaire, and pharmacokinetic plasma blood draw, respectively, at the final clinic visit (FCV). There were no Grade 2 genitourinary AEs in 47 participants completing the FCV. One participant in the DPV arm failed to attend the FCV. There were 13 AEs reported; all were Grade 1 except one Grade 2 corneal laceration unrelated to study product. Participants liked the gel to a moderate extent, yet 72% reported they would be “very likely” to use a gel like the one they used in the study every time they have intercourse. DPV was detectable in plasma in all 23 DPV arm study participants at the FCV. On average, the circumcised participants' DPV concentrations were 54% of those in uncircumcised participants (p=0.07). Topical seven-day penile application of DPV 0.05% gel was locally and systemically safe, was acceptable to male participants, and resulted in systemic exposure to the drug. PMID:24070431

  5. A randomized male tolerance study of dapivirine gel following multiple topical penile exposures (MTN 012/IPM 010).

    PubMed

    Cranston, Ross D; Hoesley, Craig; Carballo-Diéguez, Alex; Hendrix, Craig W; Husnik, Marla; Levy, Lisa; Hall, Wayne; Soto-Torres, Lydia; Nel, Annalene M

    2014-02-01

    Dapivirine (DPV) is a nonnucleoside reverse transcriptase inhibitor with a favorable safety profile following vaginal application. A penile tolerance study was conducted prior to further development of DPV as a candidate vaginal microbicide. Twenty-four circumcised and 24 uncircumcised (N=48) healthy HIV-negative male participants aged 18 years or older were randomized 2:1:1 to apply DPV 0.05% gel, matched placebo gel, or universal placebo gel, respectively, to their penis once daily for 7 sequential days. The safety, acceptability, and pharmacokinetic profile of DPV 0.05% gel were assessed by the presence of Grade 2 or higher genitourinary adverse events (AEs) and systemic AEs, a behavioral questionnaire, and pharmacokinetic plasma blood draw, respectively, at the final clinic visit (FCV). There were no Grade 2 genitourinary AEs in 47 participants completing the FCV. One participant in the DPV arm failed to attend the FCV. There were 13 AEs reported; all were Grade 1 except one Grade 2 corneal laceration unrelated to study product. Participants liked the gel to a moderate extent, yet 72% reported they would be "very likely" to use a gel like the one they used in the study every time they have intercourse. DPV was detectable in plasma in all 23 DPV arm study participants at the FCV. On average, the circumcised participants' DPV concentrations were 54% of those in uncircumcised participants (p=0.07). Topical seven-day penile application of DPV 0.05% gel was locally and systemically safe, was acceptable to male participants, and resulted in systemic exposure to the drug.

  6. Evaluation of hyaluronan gel (Gengigel(®) ) as a topical applicant in the treatment of gingivitis.

    PubMed

    Sapna, Nadiger; Vandana, Kharidi Laxman

    2011-08-01

      To clinically and histopathologically evaluate the anti-inflammatory effect of 0.2% hyaluronan gel alone and with mechanical therapy on gingivitis. The argyrophilic nucleolar organizer region staining technique was attempted to routinely determine its diagnostic and prognostic dependability for periodontal lesions.   In each of the 28 gingivitis patients, the four quadrants were subjected to different treatments: scaling, scaling + topical hyaluronan gel, only topical hyaluronan gel, and topical + intrasulcular hyaluronan gel. Clinical parameters were recorded at baseline, and on days 7, 14, and 21. Biopsies were taken from each quadrant, inflammatory infiltrates were graded, and the argyrophilic nucleolar organizer region count was measured before and after treatment.   A significant reduction was seen in clinical parameters, inflammatory infiltrates, and the argyrophilic nucleolar organizer region count within the groups. The effect of topical + intrasulcular gel was equivalent to scaling (P > 0.05). Topical + intrasulcular hyaluronan gel application demonstrated a better reduction than topical hyaluronan gel alone.   Hyaluronan gel is an effective topical agent for treating gingivitis, along with scaling and intrasulcular application. The argyrophilic nucleolar organizer region count can be used as a histopathological indicator in cases of non-responsive gingivitis to assess the severity of gingival inflammation. © 2011 Blackwell Publishing Asia Pty Ltd.

  7. The Effect of Testosterone Topical Solution in Hypogonadal Men With Suboptimal Response to a Topical Testosterone Gel.

    PubMed

    Burns, Patrick R; Kim, Edward D; Ruff, Dustin D; Seftel, Allen D

    2018-05-01

    This study evaluated the effect of axillary administration of a 2% testosterone solution (Axiron ® ) in hypogonadal (HGN) men who had had a suboptimal response to treatment with a commercially available topical testosterone gel. HGN men averaging 57 years old, with a mean body mass index of 31.9 kg/m 2 and median baseline testosterone level (T-level) of 185.2 ng/dL, who had failed to reach normal T-levels with a topical testosterone gel (Androgel 1.62%, Androgel, Testim, or Fortesta) were treated with a 2% testosterone solution until T-levels reached a normal range (from ≥300 to ≤1,050 ng/dL) or for up to 9 weeks. Outcomes included the cumulative percentage of men with a serum T-level in the normal range during treatment with Axiron and improvement in symptoms of low energy level and low sexual drive. During the study, 95% of HGN men (72/78) attained a T-level in the normal range. The median T-level at endpoint was 495.7 ng/dL, a threefold increase over baseline, p < .001, 70% achieving normal T-levels within the first 2 weeks of treatment. In a post hoc analysis, all subjects with baseline body mass indexes >35 kg/m 2 ( n = 19) achieved T-levels in the normal range. Prior to treatment, over 61% of subjects (48/78) reported impairment in either energy level or sexual drive. After treatment (or testosterone normalization), energy level improved in 75% of subjects and sexual drive improved in 70%. Topical 2% testosterone solution is a safe and effective treatment for HGN men who have had a suboptimal response to previous treatment with topical testosterone gels.

  8. Analgesic effect of topical oral capsaicin gel in burning mouth syndrome.

    PubMed

    Jørgensen, Mette Rose; Pedersen, Anne Marie Lynge

    2017-03-01

    To investigate the effectiveness of repeated topical application of oral capsaicin gel in two different concentrations for relief of burning/stinging sensations in patients with burning mouth syndrome (BMS). This randomized double-blind cross-over study included 22 female patients with BMS. The patients were randomized for topical application of either 0.01% or 0.025% oral capsaicin gel on the dorsal part of tongue three times daily for 14 days, followed by 14 days wash-out period, and finally treatment with the other concentration of oral gel three times daily for 14 days. A visual analogue scale (VAS) was used to assess the severity of pain five times during the intervention period. 18 patients completed the intervention. Their VAS score at baseline was 5.5 ± 0.6 cm (mean ± SD). Treatment with the two concentrations of capsaicin gels significantly improved the burning/stinging symptoms assessed on VAS compared with baseline (p = 0.002). There was no statistically significant difference between the two concentrations of the gels on relieving symptoms. Four patients dropped out during the intervention period due to gastrointestinal side-effects. Topical capsaicin might be an alternative for the short-term treatment of BMS. However, further studies are needed to investigate especially the gastro-intestinal side-effects which may limit its long-term use.

  9. Severe methemoglobinemia linked to gel-type topical benzocaine use: a case report.

    PubMed

    Chung, Nam-Young; Batra, Rajni; Itzkevitch, Myrzia; Boruchov, Donna; Baldauf, Mary

    2010-06-01

    Methemoglobinemia is an uncommon cause of tissue hypoxia, but it can be life threatening if it is not identified and treated promptly. To highlight the importance of understanding the potential risks of over-the-counter medications, especially in unsupervised use. Topical benzocaine must be used with caution, even in the healthy population. We report a case of methemoglobinemia secondary to topical benzocaine gel. A 6-year-old boy presented to our Pediatric Emergency Department with cyanosis, vomiting, and lethargy after using a gel-type, 7.5% benzocaine (Baby Orajel) for a toothache. Physical examination revealed dusky blue skin, tachycardia, tachypnea, and a normal neurologic examination. His percutaneous oxygen saturation remained 77-83% despite the administration of 100% oxygen. His arterial blood sample had a dark chocolate color appearance, and methemoglobinemia was suspected. His methemoglobin level was 69.9%, which is considered a lethal level. After a single dose of methylene blue (1 mg/kg/dose), cyanosis was reduced and oxygenation improved. Over-the-counter topical benzocaine should be used with caution, and the presence of methemoglobinemia must be promptly identified and treated. Copyright 2010 Elsevier Inc. All rights reserved.

  10. Topical Application of a Silicone Gel Sheet with Verapamil Microparticles in a Rabbit Model of Hypertrophic Scar.

    PubMed

    Rha, Eun Young; Kim, Yun Ho; Kim, Tae-Jung; Yoo, Gyeol; Rhie, Jong Won; Kim, Hyun-Jung; Park, Il-Kyu

    2016-01-01

    The authors developed a novel treatment based on the topical application of a silicone gel sheet containing verapamil microparticles. The ability of these silicone gel sheets to inhibit hypertrophic scar in a rabbit ear wound model was examined. Ten New Zealand White rabbits with a total of 80 wounds in both ears were used in this study. The rabbits were divided into five groups (control; silicone gel sheet; and silicone gel sheet plus 0.25, 2.5, and 25 mg of verapamil per gram). Histopathologic findings were quantified. The mean scar elevation index, fibroblast counts, and capillary counts differed significantly among the five groups (p < 0.05). The median scar elevation index was significantly lower in the silicone gel sheet plus 2.5 mg of verapamil per gram group than in the silicone gel sheet group (1.2 versus 2.2). The median number of fibroblasts was significantly lower in the silicone gel sheet plus 0.25 mg of verapamil per gram group than in the silicone gel sheet group (172.5 versus 243). In the median number of capillary lumina, there was no significant difference between the silicone gel sheet group and the silicone gel sheet plus 0.25, 2.5, and 25 mg of verapamil per gram groups (28.5, 18, 20, and 18, respectively). Topical application of a silicone gel sheet with verapamil microparticles may be a novel, effective treatment method for hypertrophic scar, but its safety and efficacy in humans must be tested in clinical trials.

  11. Microemulsion and Microemulsion-Based Gels for Topical Antifungal Therapy with Phytochemicals.

    PubMed

    Boonme, Prapaporn; Kaewbanjong, Jarika; Amnuaikit, Thanaporn; Andreani, Tatiana; Silva, Amélia M; Souto, Eliana B

    2016-01-01

    Skin fungal infections are regular injuries suffered by people living in tropical areas. Most common pathogens are Trichophyton, Microsporum and Epidermophyton which can cause skin lesions in many parts of body. Topical antifungal phytochemicals are commonly used to avoid systemic adverse events and are more convenient for patient application than those administered by other routes. However, the effectiveness of topical treatments in eradicating fungal infection is more limited since the stratum corneum acts as the skin barrier, resulting in long treatment duration and low patient's compliance. The goal of this work is to identify optimized drug delivery systems to improve topic clinical efficacy. Microemulsions i.e. liquid dispersions of oil and water stabilized with an interfacial film of surfactant are well known drug delivery systems. A thickening agent may be included to form microemulsion-based gels to increase skin adhesion. Microemulsions and microemulsion-based gels can be loaded with several hydrophilic and lipophilic drugs because they are composed of both water and oil phases. Microemulsions and microemulsion-based gels can also be used for the delivery of many drugs including antifungal drugs through stratum corneum due to their capacity to act as skin penetration enhancement. In addition to a comprehensive review of microemulsion and microemulsion-based gels as suitable carriers for skin delivery of various antifungal drugs, this review also aims to discuss the delivery of antifungal phytochemicals.

  12. Evaluation of β-blocker gel and effect of dosing volume for topical delivery.

    PubMed

    Zhang, Qian; Chantasart, Doungdaw; Li, S Kevin

    2015-05-01

    Although topical administration of β-blockers is desired because of the improved therapeutic efficacy and reduced systemic adverse effects compared with systemic administration in the treatment of infantile hemangioma, the permeation of β-blockers across skin under finite dose conditions has not been systematically studied and an effective topical β-blocker formulation for skin application is not available. The present study evaluated the permeation of β-blockers propranolol, betaxolol, and timolol across human epidermal membrane (HEM) from a topical gel in Franz diffusion cells in vitro under various dosing conditions. The effects of occlusion and dosing volume on percutaneous absorption of β-blockers from the gel were studied. The permeation data were compared with those of finite dose diffusion theory. The results showed that skin permeation of β-blockers generally could be enhanced two to three times by skin occlusion. The cumulative amounts of β-blockers permeated across HEM increased with increasing dosing volume. An adequate fit was obtained between the theoretical curve and experimental permeation data, indicating that the experimental results of the gel are consistent with finite dose diffusion theory. In conclusion, the findings suggest the feasibility of using topical gels of β-blockers for infantile hemangioma treatment and topical application with skin occlusion is preferred. © 2015 Wiley Periodicals, Inc. and the American Pharmacists Association.

  13. Lidocaine gel versus combined topical anesthesia using bupivacaine, oxybuprocaine and diclofenac eyedrops in cataract surgery.

    PubMed

    Thill, Michelle; Zeitz, Oliver; Richard, Ines; Richard, Gisbert

    2005-01-01

    To assess the safety and efficacy of two topical anesthesia regimes for cataract surgery. 21 patients received a combination of 4 times bupivacaine 0.5, oxybuprocaine and diclofenac eyedrops, 18 patients were given a single topical application of lidocaine gel 2%. A single intracameral injection of lidocaine 1% was administered to all subjects. The extent to which the surgeon was bothered by patient motility was graded as low in about two thirds of all procedures. Patients reported lower intraoperative pain levels with a single application of lidocaine gel supplemented with intracameral lidocaine than with a fourfold application of the combination topical anesthesia plus intracameral anesthesia. A single application of lidocaine gel 2% combined with intracameral anesthesia provides at least as good analgesia than multiple administration of combined topical anesthesia supplemented with intracameral anesthesia and is equally safe.

  14. Prevention of hypertrophic scars and keloids by the prophylactic use of topical silicone gel sheets following a surgical procedure in an office setting.

    PubMed

    Gold, M H; Foster, T D; Adair, M A; Burlison, K; Lewis, T

    2001-07-01

    Topical silicone gel sheeting has been used for more than 20 years to help reduce the size of hypertrophic scars and keloids. Its clinical efficacy and safety is well established. To determine whether topical silicone gel sheeting can be used to prevent hypertrophic scars and keloids from forming following dermatologic skin surgery. Patients undergoing skin surgery were stratified into two groups: those with no history of abnormal scarring (low-risk group) and those with a history of abnormal scarring (high-risk group). Following the procedure, patients within each group were randomized to receive either routine postoperative care or topical silicone gel sheeting (48 hours after surgery). Patients were followed for 6 months. In the low-risk group, there were no statistical differences between individuals using routine postoperative care or using topical silicone gel sheets. In the high-risk group, there was a statistical difference (39% versus 71%) between patients who did not develop abnormal scars and used topical silicone gel sheeting and patients who developed abnormal scars after routine postoperative treatment. Those individuals having a scar revision procedure also showed a statistical difference if topical silicone gel sheeting was used following surgery. Topical silicone gel sheeting, with a 20-year history of satisfaction in dermatology, now appears to be useful in the prevention of hypertrophic scars and keloids in patients undergoing scar revision.

  15. Nanostructured lipid carriers-based flurbiprofen gel after topical administration: acute skin irritation, pharmacodynamics, and percutaneous absorption mechanism.

    PubMed

    Song, Aihua; Su, Zhen; Li, Sanming; Han, Fei

    2015-01-01

    In order to assess the preliminary safety and effectiveness of nanostructured lipid carriers-based flurbiprofen gel (FP NLC-gel), the acute irritation test, in vivo pharmacodynamics evaluation and pharmacokinetic study were investigated after topical application. No dropsy and erythema were observed after continuous dosing 7 d of FP NLC-gel on the rabbit skin, and the xylene-induced ear drossy could be inhibited by FP NLC-gel at different dosages. The maximum concentration of FP in rats muscle was 2.03 μg/g and 1.55 μg/g after oral and topical administration, respectively. While the peak concentration in untreated muscle after topical administration was only 0.37 μg/mL. And at any time, following topical administration the mean muscle-plasma concentration ratio Cmuscle/CPlasma was obviously higher than that following oral administration. Results indicated that FP could directly penetrate into the subcutaneous muscle tissue from the administration site. Thus, the developed FP NLC-gel could be a safe and effective vehicle for topical delivery of FP.

  16. Rosemary Essential Oil-Loaded Lipid Nanoparticles: In Vivo Topical Activity from Gel Vehicles

    PubMed Central

    Montenegro, Lucia; Zappalà, Agata; Parenti, Carmela

    2017-01-01

    Although rosemary essential oil (EO) shows many biological activities, its topical benefits have not been clearly demonstrated. In this work, we assessed the effects on skin hydration and elasticity of rosemary EO after topical application via gel vehicles in human volunteers. To improve its topical efficacy, rosemary EO was loaded into lipid nanoparticles (NLCs) consisting of cetyl palmitate as a solid lipid, and non-ionic surfactants. Such NLCs were prepared using different ratios of EO/solid lipid and those containing EO 3% w/w and cetyl pamitate 7% w/w were selected for in vivo studies, showing the best technological properties (small particle size, low polydispersity index and good stability). Gels containing free EO or EO-loaded NLCs were applied on the hand skin surface of ten healthy volunteers twice a day for one week. Skin hydration and elasticity changes were recorded using the instrument Soft Plus. Gels containing EO-loaded NLCs showed a significant increase in skin hydration in comparison with gels containing free EO. Skin elasticity increased, as well, although to a lesser extent. The results of this study point out the usefulness of rosemary EO-loaded NLCs for the treatment of cutaneous alterations involving loss of skin hydration and elasticity. PMID:29065483

  17. Assessment of dermatopharmacokinetic approach in the bioequivalence determination of topical tretinoin gel products.

    PubMed

    Pershing, Lynn K; Nelson, Joel L; Corlett, Judy L; Shrivastava, Surendra P; Hare, Don B; Shah, Vinod P

    2003-05-01

    A new dermatopharmacokinetic (DPK) approach has been proposed for bioequivalence determination of topical drug products by comparing the drug content kinetics in stratum corneum. We sought to establish any correlation between clinical safety/efficacy and DPK approach in bioequivalence determination of tretinoin gel 0.025%. Tretinoin and isotretinoin were quantified in human volar forearm stratum corneum as a function of time with 3 tretinoin gel 0.025% products in 49 patients. Stratum corneum layers were harvested using multiple adhesive disks, which were subsequently extracted and quantified for both isomers by high-performance liquid chromatography. Products with similar composition and therapeutic equivalence were found bioequivalent, and products with different composition and clinical profiles were found bioinequivalent by DPK methodology. There is a direct correlation between DPK parameters in healthy patients and clinical safety/efficacy of tretinoin gel products in patients with acne. Data support the use of DPK parameters and methodology in the bioequivalence assessment of topical tretinoin gel products.

  18. Piercing Ear Keloid: Excision Using Loupe Magnification and Topical Liquid Silicone Gel as Adjuvant

    PubMed Central

    Ramesh, Bellam A.; Mohan, J.

    2018-01-01

    Background: Keloid is an abnormal growth of scar at the site of skin injury, which usually does not regress. It proliferates beyond the original scar. The ear keloid usually develops after piercing injury to wear ornaments. A patient usually asks for removal of keloid, as it is aesthetically unpleasant. Patient may sometimes complain of itching and pain. Aim: The study was conducted to analyze results following excision of keloid with its tract and topical silicone gel as the postsurgical adjuvant. Materials and Methods: Ear keloids measuring less than 0.5cm or more than 5cm in maximum dimension were excluded from the study. Nonpiercing causes such as burns, trauma, and recurrent keloid were excluded from the study. The study was carried out on 22 patients who had keloid because of piercing injury, including 4 cases with both ear keloids. Of 26 ear keloids, 19 had the tract or connecting tissue. The lesion was excised under anesthesia using magnification. For all the operated cases, topical liquid silicone gel was used as postsurgical adjuvant therapy. The method of application of topical silicone gel was taught to each patient and was considered significant. Result: The magnification helped in identification of tract in 73% of the cases in this study. Twenty patients had successfully responded to proposed treatment, and two patients developed recurrence while using topical silicone gel as the adjuvant. These two patients were managed with conventional triamcinolone injection. Conclusion: The topical silicone gel as postsurgical adjuvant therapy avoided the use of painful postsurgical injection or radiotherapy for the 1–3cm primary ear keloids. The advantages of magnification were better clearance of keloid tissue, easier identification of tract and removal of keloid pseudopods, meticulous suturing, and comfortable elevation of a small local flap. PMID:29731586

  19. Diacerein niosomal gel for topical delivery: development, in vitro and in vivo assessment.

    PubMed

    El-Say, Khalid M; Abd-Allah, Fathy I; Lila, Ahmed E; Hassan, Abd El-Saboor A; Kassem, Alaa Eldin A

    2016-01-01

    The purpose of this study was to load diacerein (DCR) in niosomes by applying response surface methodology and incorporate these niosomes in gel base for topical delivery. Box-Behnken design was used to investigate the effect of charge-inducing agent (X1), surfactant HLB (X2) and sonication time (X3) on the vesicle size (Y1), entrapment efficiency (Y2) and cumulative drug released (Y3). DCR niosomal formulations were prepared by thin film hydration method. The optimized formula was incorporated in different gel bases. DCR niosomal gels were evaluated for homogeneity, rheological behavior; in vitro release and pharmacodynamic activity by carrageenan-induced hind paw edema method in the rat compared with DCR commercial gel. The results revealed that the mean vesicle sizes of the prepared niosomes ranged from 7.33 to 23.72 µm and the entrapment efficiency ranged from 9.52% to 58.43% with controlled release pattern over 8 h. DCR niosomal gels exhibited pseudoplastic flow with thixotropic behavior. The pharmacodynamic activity of DCR niosomal gel in 3% HPMC showed significant, 37.66%, maximum inhibition of edema size in comparison with 20.83% for the commercial gel (p < 0.05). These results recommended the incorporation of DCR niosomes in 3% HPMC for topical application as a potent anti-inflammatory drug for the treatment of osteoarthritis.

  20. The influence of topical application of grapeseed extract gel on enamel surface hardness after demineralization

    NASA Astrophysics Data System (ADS)

    Saragih, D. A.; Herda, E.; Triaminingsih, S.

    2017-08-01

    The aim of this study was to analyze the influence of topical application of 6.5% and 12.5% grapeseed extract gels for duration of application 16 and 32 minutes on the enamel surface hardness following tooth demineralization by an energy drink. The samples were 21 bovine teeth that underwent demineralization by immersion in the energy drink for 5 minutes in an incubator at 37°C. The demineralized specimens were randomly divided into a control group and 2 treatment groups. The control group was immersed in artificial saliva for 6 hours at 37°C, whereas the treatment groups were treated with topical 6.5% and 12.5% grapeseed extract gels for durations of 16 and 32 minutes and then immersed in artificial saliva for 6 hours at 37°C. The hardness was measured with a Knoop hardness tester. Statistical analysis by repeated ANOVA and one-way ANOVA revealed a significant increase in the enamel hardness value (p<0.05) after the application of the topical grapeseed extract gels at both concentrations. Application of 12.5% topical grapeseed extract gel for 32 minutes resulted in a restored hardness that insignificant diffrence from the initial hardness value obtained before demineralization (p>0.05).

  1. Topical Colchicine Gel versus Diclofenac Sodium Gel for the Treatment of Actinic Keratoses: A Randomized, Double-Blind Study.

    PubMed

    Faghihi, Gita; Elahipoor, Azam; Iraji, Fariba; Behfar, Shadi; Abtahi-Naeini, Bahareh

    2016-01-01

    Introduction. Actinic keratoses (AKs), a premalignant skin lesion, are a common lesion in fair skin. Although destructive treatment remains the gold standard for AKs, medical therapies may be preferable due to the comfort and reliability .This study aims to compare the effects of topical 1% colchicine gel and 3% diclofenac sodium gel in AKs. Materials and Methods. In this randomized double-blind study, 70 lesions were selected. Patients were randomized before receiving either 1% colchicine gel or 3% diclofenac sodium cream twice a day for 6 weeks. Patients were evaluated in terms of their lesion size, treatment complications, and recurrence at 7, 30, 60, and 120 days after treatment. Results. The mean of changes in the size was significant in both groups both before and after treatment (<0.001). The mean lesion size before treatment and at 30, 60, and 120 days was not different between the two groups (p > 0.05). No case of erythema was seen in the colchicine group, while erythema was seen in 22.9% (eight cases) of patients in the diclofenac sodium group (p = 0.005). Conclusions. 1% colchicine gel was a safe and effective medication with fewer side effects and lack of recurrence of the lesion.

  2. Topical adapalene gel 0.1% vs. isotretinoin gel 0.05% in the treatment of acne vulgaris: a randomized open-label clinical trial.

    PubMed

    Ioannides, D; Rigopoulos, D; Katsambas, A

    2002-09-01

    Topical application of isotretinoin and adapalene has proved effective in treating acne vulgaris. Both drugs demonstrate therapeutic advantages and less irritancy over tretinoin, the most widely used treatment for acne. They both act as retinoid agonists, but differ in their affinity profile for nuclear and cytosolic retinoic acid receptors. To compare the efficacy and tolerability of adapalene gel 0.1% and isotretinoin gel 0.05% in the treatment of acne vulgaris of the face, in a randomized open-label clinical trial. Eighty patients were enrolled and were instructed to apply adapalene gel 0.1% or isotretinoin gel 0.05% once daily over a 12-week treatment period. Efficacy determination included noninflammatory and inflammatory lesion counts by the investigator and global evaluation of improvement. Cutaneous tolerance was assessed by determining erythema, scaling and burning with pruritus. Adapalene and isotretinoin gels were highly effective in treating facial acne. Adapalene gel produced greater reductions in noninflammatory and inflammatory lesion counts than did isotretinoin gel, but differences between treatments were not statistically significant. Adapalene gel was significantly better tolerated than isotretinoin gel during the whole treatment period. The two gels studied demonstrated comparable efficacy. When adapalene and isotretinoin were compared, significantly lower skin irritation was noted with adapalene, indicating that adapalene may begin a new era of treatment with low-irritant retinoids.

  3. High-performance liquid chromatographic method optimization for ondansetron assay in extemporaneous topical gel and in marketed products.

    PubMed

    Quamrun, Masuda; Mamoon, Rashid; Nasheed, Shams; Randy, Mullins

    2014-01-01

    The compounding and evaluation of ondansetron hydrochloride dihydrate topical gel, 2.5% w/w, were conducted in this study. The gelling agent was Carbopol 940. Ethanol 70% in purified water was used to dissolve the drug and disperse the gelling agent. A gel was formed by adding drops of 0.1 N sodium hydroxide solution. To assay this gel, we developed a simple and reproducible stability--indicating high-performance liquid chromatographic method. This method was validated for specificity, accuracy, and precision. The compounded gel was assayed in triplicate, and the average recovery was 98.3%. Ondansetron marketed products were analyzed for comparison with the compounded formulation. Assay, accuracy, and precision data of the compounded topical gel were comparable to the marketed products.

  4. A comparison of 15% azelaic acid gel and 0.75% metronidazole gel in the topical treatment of papulopustular rosacea: results of a randomized trial.

    PubMed

    Elewski, Boni E; Fleischer, Alan B; Pariser, David M

    2003-11-01

    To compare the efficacy and safety of a novel formulation of 15% azelaic acid gel (Finacea; Berlex Laboratories, Inc, Montville, NJ) with 0.75% metronidazole gel (MetroGel; Galderma Laboratories LP, Fort Worth, Tex) as topical therapy for moderate, papulopustular facial rosacea. Multicenter, double-blind, randomized, parallel-group study. Thirteen US centers. A total of 251 patients with papulopustular rosacea with persistent erythema and telangiectasia. Patients were randomized to receive azelaic acid gel or metronidazole gel twice daily for 15 weeks. Nominal and percent change in inflammatory lesion count, change in erythema and telangiectasia severity ratings, investigator's global assessment of rosacea, and investigator's and patient's overall improvement ratings. Azelaic acid gel was superior to metronidazole gel in reduction of mean nominal lesion count (-12.9 vs -10.7, respectively) (P =.003) and mean percent decrease in inflammatory lesions (-72.7% vs -55.8%, respectively) (P<.001). With respect to erythema severity, 56% of azelaic acid gel-treated patients were rated improved vs 42% of metronidazole gel-treated patients (P =.02). The effectiveness of metronidazole gel on these variables seemed to plateau after week 8, whereas azelaic acid gel demonstrated progressive improvement through week 15. Neither treatment had a clinically appreciable effect on telangiectasia. Both the investigator's global assessment (P =.02) and overall assessment of improvement (P =.005) showed a significant therapeutic advantage for azelaic acid gel. Azelaic acid gel also scored higher on the patient's overall assessment of efficacy. Both treatments were rated as having high cosmetic acceptability. No serious or systemic treatment-related adverse events were reported in either group. Use of 15% azelaic acid gel twice daily for 15 weeks demonstrated significant superiority over using 0.75% metronidazole gel in improving principal signs of rosacea (inflammatory lesions and

  5. Formulation and evaluation of optimized oxybenzone microsponge gel for topical delivery.

    PubMed

    Pawar, Atmaram P; Gholap, Aditya P; Kuchekar, Ashwin B; Bothiraja, C; Mali, Ashwin J

    2015-01-01

    Background. Oxybenzone, a broad spectrum sunscreen agent widely used in the form of lotion and cream, has been reported to cause skin irritation, dermatitis, and systemic absorption. Aim. The objective of the present study was to formulate oxybenzone loaded microsponge gel for enhanced sun protection factor with reduced toxicity. Material and Method. Microsponge for topical delivery of oxybenzone was successfully prepared by quasiemulsion solvent diffusion method. The effects of ethyl cellulose and dichloromethane were optimized by the 3(2) factorial design. The optimized microsponges were dispersed into the hydrogel and further evaluated. Results. The microsponges were spherical with pore size in the range of 0.10-0.22 µm. The optimized formulation possesses the particle size and entrapment efficiency of 72 ± 0.77 µm and 96.9 ± 0.52%, respectively. The microsponge gel showed the controlled release and was nonirritant to the rat skin. In creep recovery test it had shown highest recovery indicating elasticity. The controlled release of oxybenzone from microsponge and barrier effect of gel result in prolonged retention of oxybenzone with reduced permeation activity. Conclusion. Evaluation study revealed remarkable and enhanced topical retention of oxybenzone for prolonged period of time. It also showed the enhanced sun protection factor compared to the marketed preparation with reduced irritation and toxicity.

  6. Formulation and Evaluation of Optimized Oxybenzone Microsponge Gel for Topical Delivery

    PubMed Central

    Pawar, Atmaram P.; Gholap, Aditya P.; Kuchekar, Ashwin B.; Bothiraja, C.; Mali, Ashwin J.

    2015-01-01

    Background. Oxybenzone, a broad spectrum sunscreen agent widely used in the form of lotion and cream, has been reported to cause skin irritation, dermatitis, and systemic absorption. Aim. The objective of the present study was to formulate oxybenzone loaded microsponge gel for enhanced sun protection factor with reduced toxicity. Material and Method. Microsponge for topical delivery of oxybenzone was successfully prepared by quasiemulsion solvent diffusion method. The effects of ethyl cellulose and dichloromethane were optimized by the 32 factorial design. The optimized microsponges were dispersed into the hydrogel and further evaluated. Results. The microsponges were spherical with pore size in the range of 0.10–0.22 µm. The optimized formulation possesses the particle size and entrapment efficiency of 72 ± 0.77 µm and 96.9 ± 0.52%, respectively. The microsponge gel showed the controlled release and was nonirritant to the rat skin. In creep recovery test it had shown highest recovery indicating elasticity. The controlled release of oxybenzone from microsponge and barrier effect of gel result in prolonged retention of oxybenzone with reduced permeation activity. Conclusion. Evaluation study revealed remarkable and enhanced topical retention of oxybenzone for prolonged period of time. It also showed the enhanced sun protection factor compared to the marketed preparation with reduced irritation and toxicity. PMID:25789176

  7. Formulation and Evaluation of Antibacterial Creams and Gels Containing Metal Ions for Topical Application

    PubMed Central

    Chen, Mei X.; Alexander, Kenneth S.

    2016-01-01

    Background. Skin infections occur commonly and often present therapeutic challenges to practitioners due to the growing concerns regarding multidrug-resistant bacterial, viral, and fungal strains. The antimicrobial properties of zinc sulfate and copper sulfate are well known and have been investigated for many years. However, the synergistic activity between these two metal ions as antimicrobial ingredients has not been evaluated in topical formulations. Objective. The aims of the present study were to (1) formulate topical creams and gels containing zinc and copper alone or in combination and (2) evaluate the in vitro antibacterial activity of these metal ions in the formulations. Method. Formulation of the gels and creams was followed by evaluating their organoleptic characteristics, physicochemical properties, and in vitro antibacterial activity against Escherichia coli and Staphylococcus aureus. Results. Zinc sulfate and copper sulfate had a strong synergistic antibacterial activity in the creams and gels. The minimum effective concentration was found to be 3 w/w% for both active ingredients against the two tested microorganisms. Conclusions. This study evaluated and confirmed the synergistic in vitro antibacterial effect of copper sulfate and zinc sulfate in a cream and two gels. PMID:27885352

  8. Efficacy of topical azelaic acid gel in the treatment of mild-moderate acne vulgaris.

    PubMed

    Iraji, Fariba; Sadeghinia, Ali; Shahmoradi, Zabiholahi; Siadat, Amir Hossein; Jooya, Abolfazl

    2007-01-01

    Twenty percent azelaic acid gel is recommended as a topical treatment for acne due to its favorable profile. Our objective in this study was to evaluate the efficacy of 20% azelaic acid gel in the treatment of mild to moderate acne vulgaris. This was a double blind, randomized clinical trial. Sixty patients with mild to moderate acne vulgaris were selected randomly to receive either azelaic acid gel or the vehicle gel alone. Patients were followed up every 15 days for a period of 45 days. The number of lesions and the acne severity index (ASI) were recorded and compared using Student's t-test. Total lesion count was reduced by 60.6% and 19.9% by azelaic acid gel and the placebo respectively (P = 0.002). ASI was reduced by 65.2% and 21.3% by azelaic acid gel and the placebo respectively (P = 0.001), i.e, azelaic acid gel was 3.06 times more effective than the placebo in reducing ASI. Azelaic acid gel can be used as an effective treatment in mild to moderate acne vulgaris.

  9. Efficacy of topical azelaic acid (AzA) gel 15% plus oral doxycycline 40 mg versus metronidazole gel 1% plus oral doxycycline 40 mg in mild-to-moderate papulopustular rosacea.

    PubMed

    Del Rosso, James Q; Bruce, Suzanne; Jarratt, Michael; Menter, Alan; Staedtler, Gerald

    2010-06-01

    Rosacea is a leading reason why people seek the care of a dermatologist, accounting for nearly 7 million office visits annually. Pharmacologic treatments include both topical and oral medications, which are increasingly being used in combination, especially at the outset of therapy. This exploratory study assesses the safety, effectiveness and speed of onset of two common topical agents for the treatment of rosacea--azelaic acid gel (AzA) 15% and metronidazole gel 1%--used in conjunction with anti-inflammatory dose doxycycline (40 mg once daily). Men and women (n = 207) with mild-to-moderate papulopustular rosacea were enrolled and randomized to receive either AzA gel 15% twice daily plus doxycycline 40 mg once daily (AzA group) or metronidazole gel 1% once daily plus doxycycline 40 mg once daily (Metro group) for 12 weeks. Both regimens were safe, efficacious and well tolerated. Efficacy parameters revealed a possible trend toward greater and earlier benefit with the AzA-based regimen than with the metronidazole-based regimen. These findings warrant further investigation in a sufficiently powered study.

  10. Topical Review: Polymer gel dosimetry

    PubMed Central

    Baldock, C; De Deene, Y; Doran, S; Ibbott, G; Jirasek, A; Lepage, M; McAuley, K B; Oldham, M; Schreiner, L J

    2010-01-01

    Polymer gel dosimeters are fabricated from radiation sensitive chemicals which, upon irradiation, polymerize as a function of the absorbed radiation dose. These gel dosimeters, with the capacity to uniquely record the radiation dose distribution in three-dimensions (3D), have specific advantages when compared to one-dimensional dosimeters, such as ion chambers, and two-dimensional dosimeters, such as film. These advantages are particularly significant in dosimetry situations where steep dose gradients exist such as in intensity-modulated radiation therapy (IMRT) and stereotactic radiosurgery. Polymer gel dosimeters also have specific advantages for brachytherapy dosimetry. Potential dosimetry applications include those for low-energy x-rays, high-linear energy transfer (LET) and proton therapy, radionuclide and boron capture neutron therapy dosimetries. These 3D dosimeters are radiologically soft-tissue equivalent with properties that may be modified depending on the application. The 3D radiation dose distribution in polymer gel dosimeters may be imaged using magnetic resonance imaging (MRI), optical-computerized tomography (optical-CT), x-ray CT or ultrasound. The fundamental science underpinning polymer gel dosimetry is reviewed along with the various evaluation techniques. Clinical dosimetry applications of polymer gel dosimetry are also presented. PMID:20150687

  11. A comparison of the leaf gel extracts of Aloe ferox and Aloe vera in the topical treatment of atopic dermatitis in Balb/c mice.

    PubMed

    Finberg, M J; Muntingh, G L; van Rensburg, C E J

    2015-12-01

    Aloe vera gel is widely used in the treatment of an array of disturbances, especially skin disorders. The wound-healing effects have been attributed to its moisturizing and anti-inflammatory effects as well as its beneficial effect on the maturation of collagen. The aim of the present study is to compare the effects of topically applied extracts of Aloe ferox with that of Aloe vera on the symptoms as well as IgE levels of a mouse model of atopic dermatitis (AD). Mice were sensitized and challenged with 2,4-dinitrochlorobenzene and treated afterwards for 10 consecutive days with the gels of either A. ferox or A. vera applied topically to the affected areas. A placebo gel was used for the control mice. Blood was collected at the beginning and end of the treatment period to measure serum IgE levels. Although the gels of both the Aloe species inhibited the cutaneous inflammatory response as well as serum IgE levels in the rats, the extracts of A. ferox were superior to that of A. vera in reducing IgE levels. The gels of A. ferox and A. vera, applied topically, may be a safe and useful alternative to antihistamines and topical corticosteroids, for the treatment of patients suffering from recurring chronic AD.

  12. UV-curable gel formulations: Potential drug carriers for the topical treatment of nail diseases.

    PubMed

    Kerai, Laxmi Valji; Hilton, Stephen; Murdan, Sudaxshina

    2015-08-15

    Nail diseases are common, cause significant distress and treatments are far from successful. Our aim was to investigate the potential of UV-curable gels - currently used as cosmetics - as topical drug carriers for their treatment. These formulations have a long residence on the nail, which is expected to increase patient compliance and the success of topical therapy. The gels are composed of the diurethane dimethacrylate, ethyl methacrylate, 2-hydroxy-2-methylpropiophenone, an antifungal drug (amorolfine HCl or terbinafine HCl) and an organic liquid (ethanol or NMP) as drug solvent. Following its application to a substrate and exposure to a UVA lamp for 2 min, the gel polymerises and forms a smooth, glossy and amorphous film, with negligible levels of residual monomers. No drug-polymer interactions were found and drug loading did not affect the film's properties, such as thickness, crystallinity and transition temperatures. In contrast, the organic solvent did influence the film's properties; NMP-containing films had lower glass transition temperatures, adhesion and water resistance than ethanol-based ones. Water-resistance being a desired property, ethanol-based formulations were investigated further for stability, drug release and ungual permeation. The films were stable under accelerated stability testing conditions. Compared to terbinafine, amorolfine was released to a greater extent, had a higher ungual flux, but a lower concentration in the nailplate. However, both drugs were present at considerably high levels in the nail when their MICs are taken into account. We thus conclude that UV-curable gels are promising candidates as topical nail medicines. Copyright © 2015 The Authors. Published by Elsevier B.V. All rights reserved.

  13. Naftifine Hydrochloride Gel 2%: An Effective Topical Treatment for Moccasin-Type Tinea Pedis.

    PubMed

    Stein Gold, Linda F; Vlahovic, Tracey; Verma, Amit; Olayinka, Babajide; Fleischer, Alan B

    2015-10-01

    Naftifine hydrochloride (naftifine) is a topical antifungal of the allylamine class, displaying fungicidal and fungistatic activity. Naftifine is generally used to treat interdigital tinea pedis; however, systemic therapy is often prescribed by healthcare providers for moccasin tinea pedis. Well-controlled clinical data on topical antifungal therapy for moccasin tinea pedis is limited. The objective of this analysis is to present data from two pooled randomized, vehicle-controlled studies that evaluated efficacy of once daily topical naftifine gel 2% and vehicle at end of treatment (week 2) and at 4 weeks post-treatment in subjects with moccasin tinea pedis. At visit 1, subjects were randomized to naftifine gel 2% or vehicle groups and subjects underwent baseline mycology culture, KOH, and symptom (erythema, scaling, and pruritus) severity grading. Naftifine gel 2% and vehicle treatment were applied once daily for 2 weeks and the subjects returned at weeks 2 and 6 for efficacy evaluation (mycology culture and grading of symptom severity). A total of 1174 subjects were enrolled with interdigital tinea pedis with or without moccasin infection. Of these subjects, 674 subjects had interdigital presentation while 500 subjects had moccasin infection in addition to the interdigital presentation. All 1174 subjects with interdigital presentation satisfied the inclusion criteria of a minimum of moderate erythema and scaling, and mild pruritus. Of the 500 subjects who had moccasin presentation, 380 satisfied the same inclusion criteria as mentioned above. Since data was analyzed as observed cases, between 337 and 349 subjects had data available for analysis of efficacy. Mycologic cure is defined as a negative dermatophyte culture and KOH, treatment effectiveness is defined as mycologic cure and symptom severity scores of 0 or 1, and complete cure is defined as mycologic cure and symptoms severity scores of 0. At week 6, the cure rates in the naftifine arm vs. the vehicle were

  14. Topical simvastatin gel as a novel therapeutic modality for palatal donor site wound healing following free gingival graft procedure.

    PubMed

    Madi, Marwa; Kassem, Abeer

    2018-04-01

    Autogenous soft-tissue grafting is a commonly used procedure nowadays in dentistry. However, the prolonged healing time needed for the donor site leads to increase the patient's pain and discomfort. Statin has been observed to be beneficial in reducing bacterial burden, improving epithelization and wound healing. The aim of this study was to evaluate intra-oral topical application of simvastatin/chitosan gel (10 mg/mL) over the palatal donor site following free gingival graft (FGG) procedure. Subjects indicated for FGG procedure were divided into four groups. Group I: Simvastatin suspension (S), group II: simvastatin/chitosan gel (SC), group III: chitosan gel (C), group IV: petroleum gel (P). Treatment was applied three times/day for the following 7 days. Wound healing was evaluated at day 3, 7 and 14 post-surgery. A visual analogue scale (VAS) was used to measure the experienced discomfort at 1, 3, 5, 7 and 14 days. Statistical significant reduction in wound-healing scores was observed after 3 and 7 days for group II compared to other groups (p  = .015). A significant reduction was also observed in VAS score for group II compared to other groups at day 1, 3, 5 and 7. Topical application of S/C gel could be used as a novel therapeutic modality that improved healing and reduced pain in the palatal donor site following FGG procedure.

  15. Novel isotretinoin microemulsion-based gel for targeted topical therapy of acne: formulation consideration, skin retention and skin irritation studies

    NASA Astrophysics Data System (ADS)

    Patel, Mrunali R.; Patel, Rashmin B.; Parikh, Jolly R.; Patel, Bharat G.

    2016-04-01

    Isotretinoin was formulated in novel microemulsion-based gel formulation with the aim of improving its solubility, skin tolerability, therapeutic efficacy, skin-targeting efficiency and patient compliance. Microemulsion was formulated by the spontaneous microemulsification method using 8 % isopropyl myristate, 24 % Labrasol, 8 % plurol oleique and 60 % water as an external phase. All plain and isotretinoin-loaded microemulsions were clear and showed physicochemical parameters for the desired topical delivery and stability. The permeation profiles of isotretinoin through rat skin from selected microemulsion formulation followed zero-order kinetics. Microemulsion-based gel was prepared by incorporating Carbopol®971 in optimized microemulsion formulation having suitable skin permeation rate and skin uptake. Microemulsion-based gel showed desired physicochemical parameters and demonstrated advantage over marketed formulation in improving the skin tolerability of isotretinoin, indicating its potential in improving topical delivery of isotretinoin. The developed microemulsion-based gel may be a potential drug delivery vehicle for targeted topical delivery of isotretinoin in the treatment of acne.

  16. Safety, efficacy, and patient acceptability of lidocaine hydrochloride ophthalmic gel as a topical ocular anesthetic for use in ophthalmic procedures

    PubMed Central

    Page, Michael A; Fraunfelder, Frederick W

    2009-01-01

    Purpose: To review the current literature on safety, efficacy, and measures of surgeon and patient satisfaction with lidocaine hydrochloride gel as a tool for ocular anesthesia. Methods: Pubmed search using keywords “lidocaine gel,” “ophthalmic,” and “surgery” and compiling cross-references. Twenty-six total references were reviewed, including 15 prospective randomized controlled trials (RCTs, total N = 933, average N = 62), 6 nonrandomized prospective studies (total N = 234, average N = 39), 2 animal studies, 1 microbiologic study, and 2 letters to the editor. Results: The RCTs and nonrandomized prospective studies evaluated a number of measures including timing of onset of anesthesia, duration of anesthesia, intraoperative and postoperative pain, need for additional anesthetic applications, intracameral lidocaine levels, and adverse effects. Control groups received topical drops, subconjunctival anesthetic, retrobulbar anesthetic, or sham gel. Lidocaine gel was shown to be at least as effective for pain control as alternative therapies in all studies, with longer duration of action than topical drops. Patient and surgeon satisfaction were high, and adverse effects were rare and comparable to those for anesthetic drop formulations. Surgical settings included cataract, pterygium, trabeculectomy, strabismus, intravitreal injection, vitrectomy, and penetrating keratoplasty. Conclusions: Lidocaine gel is a safe, effective, and potentially underutilized tool for ophthalmic surgery. PMID:19898665

  17. Efficacy of topical diclofenac diethylamine gel in osteoarthritis of the knee.

    PubMed

    Niethard, Fritz U; Gold, Morris S; Solomon, Gail S; Liu, Jiun-Min; Unkauf, Markus; Albrecht, Helmut H; Elkik, Francois

    2005-12-01

    To assess the efficacy and safety of topical diclofenac diethylamine gel, 1.16%, 4 g applied qid for 3 weeks to relieve the symptoms of osteoarthritis (OA) of the knee. Patients with OA of the knee washed out their OA medications for at least 5 drug half-lives. Patients with adequately high baseline pain scores were randomized to apply either double-blind active or placebo gel for 3 weeks. Acetaminophen (up to 2 g/day) was supplied as rescue medication. In a diary, patients recorded compliance to dosing and use of rescue medication and assessed daily pain on movement, spontaneous pain, and pain relief. At weekly site visits, patients completed the Western Ontario and McMaster (WOMAC) Osteoarthritis Index Questionnaire, which includes assessment of pain, stiffness, and physical function, and assessed pain intensity "right now." At the final visit, a global assessment of treatment efficacy was completed. Of 238 randomized patients, 237 were included in the intent to treat efficacy analysis. Treatments differed significantly for daily pain on movement at Day 5, and continued on most days through end of study. Peak differences were achieved in the second week. On the primary outcome, average pain on movement over Days 1-14, diclofenac gel was significantly superior to placebo gel. Scores for all 3 WOMAC indices for diclofenac gel treatment were significantly superior to placebo at Weeks 2 and 3. A significant difference was achieved on pain intensity "right now" at all 3 weeks. At the end of the study, patients rated diclofenac gel as significantly more effective in treating the pain of OA of the knee (p = 0.03) compared to placebo. There were no safety issues concerning adverse events or laboratory values. Diclofenac gel was effective and safe for relief of symptoms of OA of the knee over 3 weeks of dosing.

  18. A cost-effectiveness analysis of calcipotriol plus betamethasone dipropionate aerosol foam versus gel for the topical treatment of plaque psoriasis.

    PubMed

    Foley, Peter; Garrett, Sinead; Ryttig, Lasse

    2018-01-24

    Calcipotriol 50 µg/g and betamethasone 0.5 mg/g dipropionate (Cal/BD) aerosol foam formulation provides greater effectiveness and improved patient preference compared with traditional Cal/BD formulations for the topical treatment of plaque psoriasis. To determine the cost-effectiveness of Cal/BD foam compared with Cal/BD gel from the Australian perspective. A Markov model was developed to evaluate the cost-effectiveness of topical Cal/BD foam and gel for the treatment of people with plaque psoriasis. Treatment effectiveness, safety, and utilities were based on a randomized control trial, resource use was informed by expert opinion, and unit costs were obtained from public sources. Outcomes were reported in terms of 1-year costs, quality-adjusted life years, and incremental cost-effectiveness ratios. All costs were reported in 2017 Australian Dollars. The model showed that patients using Cal/BD foam had more QALYs and higher costs over 1 year compared with patients using Cal/BD gel, resulting in a cost of $13,609 per QALY gained at 4-weeks. When 4 weeks of Cal/BD foam was compared with 8 weeks of Cal/BD gel treatment, Cal/BD foam was $8 less expensive and resulted in 0.006 more QALYs gained. Sensitivity analyses showed that, compared with Cal/BD ointment, Cal/BD foam was associated with an incremental cost of $15,091 per QALY gained. Cal/BD foam is the most cost-effective Cal/BD formulation for the topical treatment of patients with plaque psoriasis.

  19. Photoacoustic study of percutaneous absorption of Carbopol and transdermic gels for topic use in skin

    NASA Astrophysics Data System (ADS)

    Rossi, R. C. P.; de Paiva, R. F.; da Silva, M. D.; Barja, P. R.

    2008-01-01

    Topical medicine application has been used to treat a good number of pathological processes. Its efficacy is associated to an efficient penetration of the drug in the internal skin layers, promoting systemic effects and excluding the possibility of drug degradation by the digestive tract and hepatic elimination. This work analyzes the penetration kinetics of two soluble bases employed as vehicles for topic application: superficial gel (Carbopol 940) and transdermic (transdermal) gel. Analysis was performed with the photoacoustic technique, based upon the absorption of modulated light by a sample with subsequent conversion of the absorbed energy in heat, generating acoustic waves in the air layer adjacent to the sample. Each of the two vehicles was evaluated through in vivo (human skin) and in vitro application. Measurements in vitro employed samples of VitroSkin (synthetic material with properties similar to those of real skin, employed in the pharmaceutical industry research). Results show that the permeation was faster for the transdermal gel, both for in vivo and in vitro measurements, indicating that in vitro measurements may be utilized in qualitative, comparative permeation studies.

  20. Ultrasonication-assisted preparation and characterization of emulsions and emulsion gels for topical drug delivery.

    PubMed

    Singh, Vinay K; Behera, Baikuntha; Pramanik, Krishna; Pal, Kunal

    2015-03-01

    The current study describes the use of ultrasonication for the preparation of biphasic emulsions and emulsion gels for topical drug delivery. Sorbitan monostearate (SMS) was used as the surfactant for stabilizing the interface of sesame oil (apolar phase) and water (polar phase). Emulsions were formed at lower concentrations of SMS, whereas emulsion gels were formed at higher concentrations of SMS. The formulations were characterized by fluorescent microscopy, X-ray diffraction, viscosity, stress relaxation, spreadability, and differential scanning calorimetry studies. Fluorescence microscopy suggested formation of oil-in-water type of formulations. There was an increase in the viscosity, bulk resistance, and firmness of the formulations as the proportions of SMS was increased. The emulsion gels were viscoelastic in nature. Thermal studies suggested higher thermodynamic stability at higher proportions of either SMS or water. Metronidazole, a model antimicrobial drug, was incorporated within the formulations. The release of the drug from the formulations was found to be diffusion mediated. The drug-loaded formulations showed sufficient antimicrobial efficiency to be used as carriers for topical antimicrobial drug delivery. © 2014 Wiley Periodicals, Inc. and the American Pharmacists Association.

  1. Trends in gel dosimetry: Preliminary bibliometric overview of active growth areas, research trends and hot topics from Gore’s 1984 paper onwards

    NASA Astrophysics Data System (ADS)

    Baldock, C.

    2017-05-01

    John Gore’s seminal 1984 paper on gel dosimetry spawned a vibrant research field ranging from fundamental science through to clinical applications. A preliminary bibliometric study was undertaken of the gel dosimetry family of publications inspired by, and resulting from, Gore’s original 1984 paper to determine active growth areas, research trends and hot topics from Gore’s paper up to and including 2016. Themes and trends of the gel dosimetry research field were bibliometrically explored by way of co-occurrence term maps using the titles and abstracts text corpora from the Web of Science database for all relevant papers from 1984 to 2016. Visualisation of similarities was used by way of the VOSviewer visualisation tool to generate cluster maps of gel dosimetry knowledge domains and the associated citation impact of topics within the domains. Heat maps were then generated to assist in the understanding of active growth areas, research trends, and emerging and hot topics in gel dosimetry.

  2. Lidocaine 20% patch vs lidocaine 5% gel for topical anaesthesia of oral mucosa.

    PubMed

    Bågesund, Mats; Tabrizi, Parisa

    2008-11-01

    Topical anaesthetics are important to provide pain control at dental injection. The aim was to evaluate the effectiveness of the intraoral topical anaesthetics lidocaine 20% patch (DentiPatch) and lidocaine 5% gel. The randomized unblinded cross-over study included 31 patients (ten boys, 21 girls) aged 13.5 +/- 2.5 years. Application of lidocaine patch or gel was randomly used at first and second visit in the upper premolar region. Heart rate was measured before and at each needle insertion after 2.5, 5, and 15 min and at injection after 15 min. Discomfort and pain were expressed in visual analogue scales (VAS). Paired t-test and Mann-Whitney U-test were used for statistic analyses. Heart rate at buccal injection decreased more when the patch was used (P = 0.0149). Heart rate was lower at the second visit (P = 0.0287). Patients expressed less discomfort when the patch was used on both buccal (P = 0.0150) and palatal (P = 0.0391) site. Boys had lower heart rate and VAS pain scale ratings than girls. Good pain control can reduce the patients' anxiety level--expressed in heart rate--at the second appointment. The patch and gel seem to provide similar pain reduction at needle stick and injection of local anaesthetics.

  3. A multicenter study of topical azelaic acid 15% gel in combination with oral doxycycline as initial therapy and azelaic acid 15% gel as maintenance monotherapy.

    PubMed

    Thiboutot, Diane M; Fleischer, Alan B; Del Rosso, James Q; Rich, Phoebe

    2009-07-01

    This two-phase, multicenter study was undertaken to examine the safety and efficacy of combination therapy with oral doxycycline and topical azelaic acid (AzA) 15% gel in moderate-to-severe papulopustular rosacea and to determine the effect of subsequent maintenance monotherapy with AzA 15% gel alone. In the initial open-label, non-randomized phase of the study, subjects (n=172) received topical AzA 15% gel and oral doxycycline (100 mg), both twice daily, for < or = 12 weeks. In the second, double-blind study phase, subjects who had initially undergone at least four weeks of combination treatment in phase 1 and who achieved > or = 75% inflammatory lesion count reduction (n=136) were randomized to receive either AzA 15% gel or its vehicle twice daily for an additional 24 weeks. Assessments of efficacy were obtained at four-week intervals throughout both phases of the study and included change in inflammatory lesion count, investigator global assessment (IGA) of rosacea severity, and separate assessments of erythema and telangiectasia severity. At the last visit for each phase of the study, the investigator and participant each rated overall improvement, with the participant rating cosmetic acceptability and the investigator rating treatment as "success" or "failure" based on IGA score. During the second phase of the trial, the rate of relapse -- defined as either a 50% deterioration in the lesion count improvement from phase 1, an increase in erythema intolerable to the subject or maintenance therapy failure as judged by the investigator and/or the subject -- was obtained. Safety assessments were conducted for both phases of the study and included analysis of adverse events (AEs) and a rating of cutaneous tolerability by the subject. By week 12 of the open-label phase of the study, 81.4% of subjects had reached a 75% or greater reduction in inflammatory lesion count, and 64% of patients achieved treatment success. During the second study phase (maintenance phase

  4. Bio-based topical system for enhanced salicylic acid delivery: preparation and performance of gels.

    PubMed

    Langasco, Rita; Spada, Gianpiera; Tanriverdi, Sakine Tuncay; Rassu, Giovanna; Giunchedi, Paolo; Özer, Özgen; Gavini, Elisabetta

    2016-08-01

    New salicylic acid (SA)-loaded gels were developed using excipients made from renewable materials, and our goal was to improve drug permeation in the topical treatment of acne vulgaris. We studied the preparation parameters to obtain suitable gel formulations. Only naturally occurring polymers were used as gelling agents. Two hydrogels and three lipogels were selected and characterized in terms of drug loading, pH, viability cells, rheology, mechanical properties and in vitro permeation; these hydrogels and lipogels were compared with the traditional ointment. We also evaluated skin parameters before and after gel application. The formulations that we studied are non-Newtonian fluids; they have high drug loading and suitable mechanical properties. Lipogels exhibit a slower and more linear in vitro permeation profile compared with hydrogels. The different vehicles that we used affected drug permeation and improve patient compliance. Cytotoxicity studies suggest that all of the formulations are non-toxic. Lipogels demonstrate appropriate technological features and improved performance compared with the traditional ointment with regard to their composition. Lipogels may represent a new bio-based topical system for SA delivery. The use of 'green' excipients leads to 'skin-friendly' formulations that are able to satisfy environmental safety. © 2016 Royal Pharmaceutical Society.

  5. Topical Oxybutynin 10% Gel for the Treatment of Primary Focal Hyperhidrosis: A Randomized Double-blind Placebo-controlled Split Area Study.

    PubMed

    Artzi, Ofir; Loizides, Christophoros; Zur, Eyal; Sprecher, Eli

    2017-10-02

    Limited efficacy, costs, side-effects and complications are issues of concern for most current therapeutic modalities for focal hyperhidrosis. This study evaluated the efficacy of topical oxybutynin 10% gel in treating 61 patients with primary focal hyperhidrosis. The gel was applied to the right or left axilla, palms or soles vs. a placebo compound to the contralateral side for 30 days. A blinded visual grading of the change in starch-iodine tests was performed by 2 non-involved physicians. The Hyperhidrosis Disease Severity Scale (HDSS) and Dermatology Life Quality Index (DLQI) questionnaires were administered before and after treatment. The patients rated their satisfaction with treatment. Fifty-three patients completed the 4-week treatment. Sweat reduction in the drug-treated sweating areas was higher than in the control-treated areas. There was a significant mean improvement in pre- and post-treatment HDSS and DQLI (p = 0.001 for both). Thirty-nine subjects (74%) reported moderate-to-high satisfaction. Twice-daily topical application of oxybutynin 10% gel appears to be an effective, safe and well-tolerated treatment for focal primary hyperhidrosis.

  6. UV-curable gels as topical nail medicines:In vivo residence, anti-fungal efficacy and influence of gel components on their properties.

    PubMed

    Kerai, L V; Hilton, S; Maugueret, M; Kazi, B B; Faull, J; Bhakta, S; Murdan, S

    2016-11-30

    UV-curable gels, used as nail cosmetics for their in vivo durability, were reported to be promising as topical nail medicines. Our first aim was thus to investigate whether such durability applies to drug-loaded formulations. This was found to be true. However, ethanol inclusion in the pharmaceutical formulation (to enable drug loading) reduced the in vivo residence. The second aim was therefore to determine any other effects of ethanol, and if ethanol could be avoided by the choice of monomers. Thus, three methacrylate monomers, ethyl methacrylate, isobornyl methacrylate and 2-hydroxyethyl methacrylate (HEMA) were selected, and their influence on the formulation properties were determined. Ethanol and the methacrylate monomer influenced some (but not all) of the formulation properties. The most significant was that HEMA could dissolve drug and enable the preparation of ethanol-free, drug-loaded formulations, which would benefit in vivo residence. The absence of ethanol reduced drug loading, release and ungual flux, but had no negative impact on the in vitro anti-fungal efficacy. Thus, judicious selection of gel components enabled the exclusion of ethanol. The long in vivo residence, little residual monomers, sufficient ungual permeation and in vitro anti-fungal activity of the gels indicates their potential as anti-onychomycotic topical medicines. Copyright © 2016 Elsevier B.V. All rights reserved.

  7. Efficacy and safety of topical diclofenac/menthol gel for ankle sprain: A randomized, double-blind, placebo- and active-controlled trial

    PubMed Central

    Collaku, Agron; Reed, Kenneth

    2017-01-01

    Purpose This study was performed to evaluate topical 1% diclofenac/3% menthol gel in treating ankle sprain. Design In this randomized, double-blind, placebo-controlled trial, adolescents and adults with acute ankle sprain (N = 385) applied 4 g of gel containing 1% diclofenac/3% menthol (n = 117), 1% diclofenac (n = 112), 3% menthol (n = 77), or placebo (n = 75) four times daily. The primary outcome was the area under the curve of pain intensity (PI) on movement [0 (no pain) to 10 (extreme pain)] from 24 to 72 hours post-application (AUC1–3 days). Secondary outcomes included pain relief (PR); PI; time to onset of PR, meaningful PR, cooling, and complete recovery; PI difference; sum of PI difference; total PR; reduction in ankle swelling; and the patient’s global assessment of response to treatment. Results There were no statistically significant differences in AUC1–3 between 1% diclofenac/3% menthol and placebo, diclofenac, or menthol gels and no meaningful advantages of 1% diclofenac/3% menthol for any secondary outcome. There was a higher incidence of skin and application-site events with 1% diclofenac/3% menthol than with placebo or 1% diclofenac. Conclusion No significant improvement was observed with topical 1% diclofenac/3% menthol gel compared with placebo, 1% diclofenac, or 3% menthol gel in treating pain from ankle sprain. ClinicalTrials.Gov Identifier: NCT02100670 PMID:28345425

  8. The effect of topical application of 0.15% ganciclovir gel on cytomegalovirus corneal endotheliitis.

    PubMed

    Koizumi, Noriko; Miyazaki, Dai; Inoue, Tomoyuki; Ohtani, Fumie; Kandori-Inoue, Michiko; Inatomi, Tsutomu; Sotozono, Chie; Nakagawa, Hiroko; Horikiri, Tomoko; Ueta, Mayumi; Nakamura, Takahiro; Inoue, Yoshitsugu; Ohashi, Yuichi; Kinoshita, Shigeru

    2017-02-01

    The aim of this study was to evaluate the therapeutic efficacy and drug transfer of topical application of 0.15% ganciclovir (GCV) gel on cytomegalovirus (CMV) corneal endotheliitis. This study is a multicentre, prospective, interventional case series. Seven eyes of seven immunocompetent patients diagnosed with CMV corneal endotheliitis, based on clinical manifestations and qualitative PCR, were enrolled in this study. The patients were treated with topical applications of 0.15% GCV gel six times daily for 12 weeks without concomitant systemic GCV. Clinical evaluations and quantitative PCR of CMV were performed, and GCV concentrations in aqueous humour were measured by liquid chromatography/tandem mass spectrometry. Clinical improvement of coin-shaped lesions, other types of keratic precipitates, corneal oedema, and anterior chamber inflammation was confirmed at the 4-week visit in all seven eyes. The GCV treatment significantly decreased the CMV copy numbers (p<0.0001). After 12 weeks of treatment, six eyes recovered clear corneas with good vision, and endothelial function was well maintained. Detectable levels of GCV were confirmed in the aqueous humour of all the eyes. The mean GCV concentration in the anterior chamber was 162.0±202.4 ng/mL. The re-emergence of CMV without symptoms was observed in one eye with lower drug transfer. No side effects were observed. Clinical improvement and reduced CMV copy numbers in the aqueous humour were confirmed in the CMV corneal endotheliitis cases. Although the case numbers are limited and long-term follow-up is necessary, the topical application of 0.15% GCV gel appears to be a useful treatment option for CMV endotheliitis. UMIN000012435. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  9. Anti-inflammatory activity of Achillea and Ruscus topical gel on carrageenan-induced paw edema in rats.

    PubMed

    Maswadeh, Hamzah M; Semreen, Mohammad H; Naddaf, Ahmad R

    2006-01-01

    The anti-inflammatory activity of Achillea and Ruscus extracts was studied in comparison with diclofenac sodium topical gel (diclosal Emulgel), using the carrageenan induced paw edema model in Albino rats. Gel formulation was prepared containing 6% of each extract in gel base, namely sodium carboxymethylcellulose (NaCMC). The kinetics of drug release from the prepared formulation was studied separately in each case. Results showed that the release follows the Higuchi square root equation. The pharmacological screening revealed that the percent reduction of edema for Achillea extract and Ruscus extract were 48.1% and 18.8%, respectively, while diclosal Emulgel produced 47% reduction of edema.

  10. Efficacy and tolerability of a topical gel containing 3% hydrogen peroxide, 1.5% salicylic acid and 4% D-panthenol in the treatment of mild-moderate acne.

    PubMed

    Fabbrocini, Gabriella; Panariello, Luigia

    2016-06-01

    The aim of this paper was to evaluate efficacy and tolerability of a topical gel (ACNAID TM gel medical device) containing 3% hydrogen peroxide (HPO), 1.5% salicylic acid (SA) and 4% D-panthenol (D-p) in the treatment of mild-moderate acne, comparing it with a previous formulation (ACNAID TM gel Cosmetic) containing 4% HPO, 0.5% SA, 4% D-p. Twenty patients of both sex with mild-moderate acne have been selected. The topical gel was applied twice a day for 60 days. Evaluations included: Global Acne Grading System (GAGS); lesions count; photographic assessment; a questionnaire to assess the tolerability. The results have been compared with those obtained in a previous study conducted with the formulation containing 4% HPO, 0.5% SA, 4% D-p. The GAGS score showed a reduction of 43% from T0 to T1 and of 61% from T0 to T2. Count of lesions: comedones reduction of 62% from T0 to T1 and of 95% from T0 to T2; papules reduction of 49% from T0 to T1 and of 68% from T0 to T2; pustules reduction of 75% from T0 to T1 and of 100% from T0 to T2. Digital images showed a significant reduction of acne lesions. At T2 the tolerability of the topical product was excellent according to 83% of patients and good according to 17% of patients. The topical gel has demonstrated to be effective and safe for treatment of mild to moderate acne. No patients reported side effects. These results are superior to those obtained in the previous study.

  11. Liposomal-benzocaine gel formulation: correlation between in vitro assays and in vivo topical anesthesia in volunteers.

    PubMed

    Franz-Montan, Michelle; Cereda, Cintia Maria Saia; Gaspari, Adele; da Silva, Camila Morais Gonçalves; de Araújo, Daniele Ribeiro; Padula, Cristina; Santi, Patrizia; Narvaes, Eliene; Novaes, Pedro Duarte; Groppo, Francisco Carlos; de Paula, Eneida

    2013-03-01

    The aim of the present study was to characterize a liposome-based benzocaine (BZC) formulation designed for topical use on the oral mucosa and to evaluate its in vitro retention and permeation using the Franz-type diffusion cells through pig esophagus mucosa. To predict the effectiveness of new designed formulations during preclinical studies, a correlation between in vitro assays and in vivo efficacy was performed. Liposomal BZC was characterized in terms of membrane/water partition coefficient, encapsulation efficiency, size, polydispersity, zeta potential, and morphology. Liposomal BZC (BL10) was incorporated into gel formulation and its performances were compared to plain BZC gel (B10) and the commercially available BZC gel (B20). BL10 and B10 presented higher flux and retention on pig esophagus mucosa with a shorter lag time, when compared to B20. BZC flux was strongly correlated with in vivo anesthetic efficacy, but not with topical anesthesia duration. The retention studies did not correlate with any of the in vivo efficacy parameters. Thus, in vitro permeation study can be useful to predict anesthetic efficacy during preclinical tests, because a correlation between flux and anesthetic efficacy was observed. Therefore, in vitro assays, followed by in vivo efficacy, are necessary to confirm anesthetic performance.

  12. Transport Properties and Magnetoresistance of La0.8Ca0.13Ag0.07MnO3 Perovskite Manganite Synthesized by Sol-Gel Method

    NASA Astrophysics Data System (ADS)

    Kurniawan, B.; Ruli, F.; Imaduddin, A.; Kamila, R.

    2018-05-01

    In this paper, we investigate the transport properties and magnetoresistance effect of La0.8Ca0.13Ag0.07MnO3 perovskite manganite synthesized by sol-gel method. The XRD pattern of the sample shows a rhombohedral perovskite structure with space group R3¯c. The EDX analysis confirms that the sample contains all expected chemical elements without any additional impurity. The temperature dependence of electrical resistivity was measured using a cryogenic magnetometer. The results show a metal-insulator transition temperature (TM-I ) at 280 K. The resistivity of the sample increases with an increase of temperature below TM-I . Theoretical analyses of the temperature dependence of resistivity suggest that the resistivity due to electron-electron scattering is predominant below TI-M. The resistivity of the sample decreases when applied magnetic field 1 T at a temperature range of 10 K to 300 K. The magnetoresistance of La0.8Ca0.13Ag0.07MnO3 emanates from spin-polarized tunneling process at the grain boundary.

  13. Evaluation of the activity and safety of CS21 barrier genital gel® compared to topical aciclovir and placebo in symptoms of genital herpes recurrences: a randomized clinical trial.

    PubMed

    Khemis, A; Duteil, L; Tillet, Y; Dereure, O; Ortonne, J-P

    2014-09-01

    Topical or systemic antiviral drugs reduce the duration of genital herpes recurrences but may not always alleviate functional symptoms. To assess the efficacy and safety of oxygenated glycerol triesters-based CS21 barrier genital gel(®) vs. topical aciclovir and placebo (vehicle) in resolving functional symptoms and in healing of genital herpes recurrences. A prospective randomized controlled, investigator-blinded trial of CS21 barrier genital gel(®) vs. topical aciclovir (reference treatment) and placebo (vehicle) was designed. The primary endpoint was the cumulative score of four herpes-related functional symptoms (pain, burning, itching and tingling sensations). Secondary endpoints included objective skin changes (erythema, papules, vesicles, oedema, erosion/ulceration, crusts), time to heal, local tolerance and overall acceptability of the treatment as reported by a self-administered questionnaire. Overall, 61 patients were included. CS 21 barrier genital gel(®) was significantly more efficient than topical aciclovir and vehicle for subjective symptoms and pain relief in genital herpes recurrences; additionally, time to heal was significantly shorter with CS 21 than with vehicle, whereas no significantly difference was observed between patients receiving topical aciclovir and vehicle. The treatments under investigation were well tolerated and the adverse events were comparable in the three treatment groups. Overall, these results support the interest of using of CS 21 barrier genital gel(®) in symptomatic genital herpes recurrences. Accordingly, this product offers a valuable alternative in topical management of recurrent genital herpes. © 2013 European Academy of Dermatology and Venereology.

  14. Randomized control trial of topical clonidine for treatment of painful diabetic neuropathy

    PubMed Central

    Campbell, Claudia M.; Kipnes, Mark S.; Stouch, Bruce C.; Brady, Kerrie L.; Kelly, Margaret; Schmidt, William K.; Petersen, Karin L.; Rowbotham, Michael C.; Campbell, James N.

    2012-01-01

    A length-dependent neuropathy with pain in the feet is a common complication of diabetes (painful diabetic neuropathy, PDN). It was hypothesized that pain may arise from sensitized-hyperactive cutaneous nociceptors, and that this abnormal signaling may be reduced by topical administration of the α2-adrenergic agonist, clonidine, to the painful area. This was a randomized, double-blind, placebo-controlled, parallel-group, multi-center trial. Nociceptor function was measured by determining the painfulness of 0.1% topical capsaicin applied to the pre-tibial area of each subject for 30 minutes during screening. Subjects were then randomized to receive 0.1% topical clonidine gel (n=89) or placebo gel (n=90) applied t.i.d. to their feet for 12 weeks. The difference in foot pain at week 12 in relation to baseline, rated on a 0-10 numerical pain rating scale (NPRS), was compared between groups. Baseline NPRS was imputed for missing data for subjects who terminated the study early. The subjects treated with clonidine showed a trend toward decreased foot pain compared to the placebo-treated group (the primary endpoint; p=0.07). In subjects who felt any level of pain to capsaicin, clonidine was superior to placebo (p<0.05). In subjects with a capsaicin pain rating ≥2 (0-10, NPRS), the mean decrease in foot pain was 2.6 for active compared to 1.4 for placebo (p=0.01). Topical clonidine gel significantly reduces the level of foot pain in PDN subjects with functional (and possibly sensitized) nociceptors in the affected skin as revealed by testing with topical capsaicin. Screening for cutaneous nociceptor function may help distinguish candidates for topical therapy for neuropathic pain. PMID:22683276

  15. Intranasal delivery of ciprofloxacin to rats: A topical approach using a thermoreversible in situ gel.

    PubMed

    Sousa, Joana; Alves, Gilberto; Oliveira, Paula; Fortuna, Ana; Falcão, Amílcar

    2017-01-15

    Intranasal administration of antibiotics is an alternative and attractive delivery approach in the treatment of local infections such as chronic rhinosinusitis. This topical route has the advantage of delivering high drug concentrations directly to the site of infection when trying to eradicate the highly resistant bacterial biofilms. The purpose of this study was to assess and compare the pharmacokinetic parameters of ciprofloxacin following intranasal and intravenous administrations to rats in plasma, olfactory bulb and nasal mucosa of two different nasal regions. For intranasal administration a thermoreversible in situ gel was used to increase drug residence time in nasal cavity. Ciprofloxacin concentration time-profile in nasal mucosa of the studied anterior region (at naso- and maxilloturbinates level) was markedly higher after intranasal administration (0.24mg/kg) than that following intravenous administration (10mg/kg), while in nasal mucosa of the more posterior region (at ethmoidal turbinates level) ciprofloxacin concentrations were found to be higher after intranasal administration when the different dose administered by both routes is taken into account. A plateau in ciprofloxacin concentration was observed in nasal mucosa of both studied regions after intranasal administration, suggesting a slow delivery of the drug over a period of time using the nasal gel formulation. In plasma and olfactory bulb, concentration of ciprofloxacin was residual after intranasal administration, which demonstrates this is a safe administration route by preventing systemic and particularly central nervous system adverse effects. Dose-normalized pharmacokinetic parameters of ciprofloxacin exposure to nasal mucosa revealed higher values after intranasal delivery not only in the anterior region but also in the posterior nasal region. In conclusion, topical intranasal administration appears to be advantageous for delivering ciprofloxacin to the biophase, with negligible systemic

  16. Delivery of adapalene using a novel topical gel based on tea tree oil nano-emulsion: Permeation, antibacterial and safety assessments.

    PubMed

    Najafi-Taher, Roqya; Ghaemi, Behnaz; Amani, Amir

    2018-07-30

    The aim of present study was to design and optimize 0.1% adapalene loaded nano-emulsion to improve the drug efficacy and increase its user compliance. Effect of type and concentration of surfactants was studied on size of 0.1% adapalene loaded nano-emulsion. Optimized formulation was then evaluated for particle size, polydispersity index, morphology, viscosity, and pH. Subsequently, 1% carbopol® 934 was incorporated to the optimized formulation for preparation of its gel form. The efficacy and safety of 0.1% adapalene loaded nano-emulsion gel was assessed compared to marketed gel containing 0.1% adapalene. In-vitro studies showed that adapalene permeation through the skin was negligible in both adapalene loaded nano-emulsion gel and adapalene marketed gel. Furthermore, drug distribution studies in skin indicated higher retention of adapalene in the dermis in adapalene loaded nano-emulsion gel compared with adapalene marketed gel. Antibacterial activity against Propionibacterium acnes showed that adapalene loaded nano-emulsion is effective in reducing minimum inhibitory concentration of the formulation in comparison with tea tree oil nano-emulsion, and pure tea tree oil. In vivo skin irritation studies showed absence of irritancy for adapalene loaded nano-emulsion gel. Also, blood and liver absorption of the drug, histological analysis of liver and liver enzyme activity of rats after 90 days' treatment were investigated. No drug was detected in blood/liver which in addition to an absence of any adverse effect on liver and enzymes showed the potential of adapalene loaded nano-emulsion gel as a novel carrier for topical delivery of adapalene. Copyright © 2018 Elsevier B.V. All rights reserved.

  17. Comparative effect of topical silicone gel and topical tretinoin cream for the prevention of hypertrophic scar and keloid formation and the improvement of scars.

    PubMed

    Kwon, S Y; Park, S D; Park, K

    2014-08-01

    Numerous modalities have been used to treat keloids and hypertrophic scars; however, optimal treatment has not yet been established. Therefore, prevention is the mainstay. Recently, silicone gel and tretinoin cream have been shown to be useful for the prevention of hypertrophic scars and keloids. However, there has been no comparative study of the two topical agents thus far. To determine and compare the effectiveness of silicone gel and tretinoin cream for the prevention of hypertrophic scars and keloids resulting from postoperative wounds and for scar improvement. This study included 26 patients with 44 different wounds. The postoperative wounds were divided into two treatment groups and one control group. The patients in the first and second treatment group applied silicone gel and tretinoin cream, respectively, twice a day on their wounds after their stitches were removed. In contrast, the control group patients did not apply anything. We used the Modified Vancouver Scar Scale to quantitatively examine the effectiveness of silicone gel and tretinoin cream just after stitches removal, and at 4, 8, 12 and 24 weeks after removal of the stitches. The silicone gel and tretinoin cream effectively prevented hypertrophic scars and keloids and improved scar effects in the two treatment groups compared with those in the control group. However, no significant difference was noted between the two treatment groups. To prevent hypertrophic scars and keloids and improve scars after surgery, application of a silicone gel or a tretinoin cream to the wounds is needed. © 2013 European Academy of Dermatology and Venereology.

  18. Novel microemulsion-based gels for topical delivery of indomethacin: Formulation, physicochemical properties and in vitro drug release studies.

    PubMed

    Froelich, Anna; Osmałek, Tomasz; Snela, Agnieszka; Kunstman, Paweł; Jadach, Barbara; Olejniczak, Marta; Roszak, Grzegorz; Białas, Wojciech

    2017-12-01

    Microemulsion-based semisolid systems may be considered as an interesting alternative to the traditional dosage forms applied in topical drug delivery. Mechanical properties of topical products are important both in terms of application and dosage form effectiveness. In this study we designed and evaluated novel microemulsion-based gels with indomethacin and analyzed the factors affecting their mechanical characteristics and drug release. The impact of the microemulsion composition on the extent of isotropic region was investigated with the use of pseudoternary phase diagrams. Selected microemulsions were analyzed in terms of electrical conductivity and surface tension in order to determine the microemulsion type. Microemulsions were transformed into polymer-based gels and subjected to rheological and textural studies. Finally, the indomethacin release from the analyzed gels was studied and compared to commercially available product. The extent of isotropic domain in pseudoternary phase diagrams seems to be dependent on the polarity of the oil phase. The surface tension and conductivity monitored as a function of water content in microemulsion systems revealed possible structural transformations from w/o through bicontinuous systems into o/w. The mechanical properties of semisolid microemulsion-based systems depended on the composition of surface active agents and the drug presence. The drug release profiles observed in the case of the investigated gels differed from those recorded for the commercially available product which was most probably caused by the different structure of both systems. Copyright © 2017 Elsevier Inc. All rights reserved.

  19. Temperature-sensitive microemulsion gel: an effective topical delivery system for simultaneous delivery of vitamins C and E.

    PubMed

    Rozman, Branka; Zvonar, Alenka; Falson, Francoise; Gasperlin, Mirjana

    2009-01-01

    Microemulsions (ME)--nanostructured systems composed of water, oil, and surfactants--have frequently been used in attempts to increase cutaneous drug delivery. The primary objective addressed in this work has been the development of temperature-sensitive microemulsion gel (called gel-like ME), as an effective and safe delivery system suitable for simultaneous topical application of a hydrophilic vitamin C and a lipophilic vitamin E. By changing water content of liquid o/w ME (o/w ME), a gel-like ME with temperature-sensitive rheological properties was formed. The temperature-driven changes in its microstructure were confirmed by rotational rheometry, viscosity measurements, and droplet size determination. The release studies have shown that the vitamins' release at skin temperature from gel-like ME were comparable to those from o/w ME and were much faster and more complete than from o/w ME conventionally thickened with polymer (o/w ME carbomer). According to effectiveness in skin delivery of both vitamins, o/w ME was found the most appropriate, followed by gel-like ME and by o/w ME carbomer, indicating that no simple correlation between vitamins release and skin absorption could be found. The cytotoxicity studies revealed good cell viability after exposure to ME and confirmed all tested microemulsions as nonirritant.

  20. Formulation of topical bioadhesive gel of aceclofenac using 3-level factorial design.

    PubMed

    Singh, Sanjay; Parhi, Rabinarayan; Garg, Anuj

    2011-01-01

    The objective of this work was to develop bioadhesive topical gel of Aceclofenac with the help of response-surface approach. Experiments were performed according to a 3-level factorial design to evaluate the effects of two independent variables [amount of Poloxamer 407 (PL-407 = X1) and hydroxypropylmethyl cellulose K100 M (HPMC = X2)] on the bioadhesive character of gel, rheological property of gel (consistency index), and in-vitro drug release. The best model was selected to fit the data. Mathematical equation was generated by Design Expert® software for the model which assists in determining the effect of independent variables. Response surface plots were also generated by the software for analyzing effect of the independent variables on the response. Quadratic model was found to be the best for all the responses. Both independent variable (X1 and X2) were found to have synergistic effect on bioadhesion (Y1) but the effect of HPMC was more pronounced than PL-407. Consistency index was enhanced by increasing the level of both independent variables. An antagonistic effect of both independent variables was found on cumulative percentage release of drug in 2 (Y3) and 8 h (Y4). Both independent variables approximately equally contributed the antagonistic effect on Y3 whereas antagonistic effect of HPMC was more pronounced than PL-407. The effect of formulation variables on the product characteristics can be easily predicted and precisely interpreted by using a 3-level factorial experimental design and generated quadratic mathematical equations.

  1. Pharmacokinetics of timolol in aqueous humor sampled by microdialysis after topical administration of thermosetting gels.

    PubMed

    Wei, Gang; Ding, Ping-Tian; Zheng, Jun-Min; Lu, Wei-Yue

    2006-01-01

    In order to develop a thermosetting gel-based formulation, the ocular pharmacokinetics of timolol was studied utilizing microdialysis sampling technique after topical administration. A linear microdialysis probe was characterized and implanted in the anterior chamber of a rabbit. Dialysate samples collected from the aqueous humor (AH) were directly injected into the HPLC system without any pre-treatment and no interference was observed in the blank sample. The measured in vitro recovery of the probe was 57.67%; however, the in vivo recovery significantly decreased to 16.78% when assessed by the retrodialysis method, which was used to calculate the timolol concentration in AH. Although in the initial 15 min the drug concentrations in AH were comparable to that of the timolol solution, increased Cmax and significantly improved ocular bioavailability were obtained for the gel. When sodium deoxycholate (DC) was incorporated in the gel as a penetration enhancer, a 2-fold increment in the ocular bioavailability was achieved with an increased Cmax and significantly suspended Tmax. The results demonstrated that microdialysis coupled to HPLC is a powerful tool to investigate the ocular pharmacokinetic, and hence facilitates the design of ophthalmic formulations. Copyright 2005 John Wiley & Sons, Ltd.

  2. Synergistically enhanced transdermal permeation and topical analgesia of tetracaine gel containing menthol and ethanol in experimental and clinical studies.

    PubMed

    Fang, Chao; Liu, Yi; Ye, Xun; Rong, Zheng-xing; Feng, Xue-mei; Jiang, Chan-bing; Chen, Hong-zhuan

    2008-03-01

    The aim of this study is to observe the synergistically enhanced percutaneous penetration and skin analgesia of tetracaine gel containing menthol and ethanol through experimental and clinical studies. Four anesthetic gels containing 4% tetracaine in carbomer vehicle named T-gel (containing no menthol or ethanol), 5%M/T-gel (containing 5% menthol), 70%E/T-gel (containing 70% ethanol, an optimal concentration for antiseptic), and 5%M+70%E/T-gel (containing both 5% menthol and 70% ethanol), respectively, were fabricated. The in vitro mouse skin permeation was investigated using a Franz diffusion cell. The mouse skin morphology was examined by a scanning electron microscope. The in vivo skin analgesic effect in mice was evaluated using the von Frey tests. To determine the efficacy of tetracaine gels for managing the pain in human volunteers, a paralleled, double-blinded, placebo-controlled, randomized controlled trial design combined with verbal pain scores (VPS) was performed. The combination of menthol and ethanol (5%M+70%E/T-gel) conferred significantly higher tetracaine diffusion across full-thickness mouse skin than 5%M/T-gel, 70%E/T-gel, and T-gel. The ultra structure changes of mouse skin stratum corneum treated with 5%M+70%E/T-gel were more marked compared with those of any other tetracaine gel. von Frey tests in mice showed a synergistically enhanced effect of menthol and ethanol on the analgesia of tetracaine gel. The mean VPS were significantly lower for volunteers treated with 5%M+70%E/T-gel than those receiving other gels or the EMLA cream. 5%M+70%E/T-gel possessed the shortest anesthesia onset time, the longest anesthesia duration and the strongest anesthesia efficacy. Seventy percent ethanol in 5%M+70%E/T-gel not only improved the analgesic efficacy of the tetracaine gel through synergistically enhanced percutaneous permeation with menthol but also served as an antiseptic agent keeping drug application site from infection. 5%M+70%E/T-gel is a potential

  3. Effect of Aloe vera topical gel combined with tretinoin in treatment of mild and moderate acne vulgaris: a randomized, double-blind, prospective trial.

    PubMed

    Hajheydari, Zohreh; Saeedi, Majid; Morteza-Semnani, Katayoun; Soltani, Aida

    2014-04-01

    Topical retinoids are considered first-line therapy in the treatment of acne vulgaris, yet can be associated with cutaneous irritations. Combination therapy with natural preparations could be effective in treatment and decreasing adverse events. The aim of this study was to compare the efficacy and safety of the combination of tretinoin (TR) cream (0.05%) and Aloe vera topical gel (50%) with TR and vehicle. The randomized, double-blind, prospective 8-week trial evaluated inflammatory and non-inflammatory lesion scores and tolerability in 60 subjects with mild to moderate acne vulgaris (global acne grading system scale). Several formulations of A. vera leaf gel were prepared and the most stable one was selected for clinical study based on physicochemical evaluations. The combination therapy showed superior efficacy to TR and placebo. TR/Aloe vera gel (AVG) was significantly more effective in reducing non-inflammatory (p = 0.001), inflammatory (p = 0.011) and total (p = 0.003) lesion scores than control group. The highest percentage of adverse cutaneous effect was reported for scaling. At the end of study, erythema in the TR/AVG-treated group was significantly less severe (p = 0.046). The combination TR/AVG was well tolerated and significantly more effective than TR and vehicle for the treatment of mild to moderate acne vulgaris.

  4. Ocular and systemic pharmacokinetics of lidocaine hydrochloride ophthalmic gel in rabbits after topical ocular administration.

    PubMed

    Liu, Bing; Ding, Li; Xu, Xiaowen; Lin, Hongda; Sun, Chenglong; You, Linjun

    2015-12-01

    Lidocaine hydrochloride ophthalmic gel is a novel ophthalmic preparation for topical ocular anesthesia. The study is aimed at evaluating the ocular and systemic pharmacokinetics of lidocaine hydrochloride 3.5 % ophthalmic gel in rabbits after ocular topical administration. Thirty-six rabbits were randomly placed in 12 groups (3 rabbits per group). The rabbits were quickly killed according to their groups at 0 (predose), 0.0833, 0.167, 0.333, 0.667, 1, 1.5, 2, 3, 4, 6, and 8 h postdose and then the ocular tissue and plasma samples were collected. All the samples were analyzed by a validated LC-MS/MS method. The test result showed that the maximum concentration (C max) of lidocaine in different ocular tissues and plasma were all achieved within 20 min after drug administration, and the data of C max were (2,987 ± 1814) μg/g, (44.67 ± 12.91) μg/g, (26.26 ± 7.19) μg/g, (11,046 ± 2,734) ng/mL, and (160.3 ± 61.0) ng/mL for tear fluid, cornea, conjunctiva, aqueous humor, and plasma, respectively. The data of the elimination half-life in these tissues were 1.5, 3.2, 3.5, 1.9, and 1.7 h for tear fluid, cornea, conjunctiva, aqueous humor, and plasma, respectively. The intraocular lidocaine levels were significantly higher than that in plasma, and the elimination half-life of lidocaine in cornea, conjunctiva, and aqueous humor was relatively longer than that in tear fluid and plasma. The high intraocular penetration, low systemic exposure, and long duration in the ocular tissues suggested lidocaine hydrochloride 3.5 % ophthalmic gel as an effective local anesthetic for ocular anesthesia during ophthalmic procedures.

  5. Development and Application of a High-Performance Liquid Chromatography Stability-Indicating Assay for Beyond-Use Date Determination of Compounded Topical Gels Containing Multiple Active Drugs.

    PubMed

    Gorman, Gregory; Sokom, Simara; Coward, Lori; Arnold, John J

    2017-01-01

    Topical gels compounded by pharmacists are important clinical tools for the management of pain. Nevertheless, there is often a dearth of information about the chemical stability of drugs included in these topical formulations, complicating the assignment of beyond-use dating. The purpose of this study was to develop a high-performance liquid chromatography photodiode array-based stability-indicating assay that could simultaneously resolve six drugs (amitriptyline, baclofen, clonidine, gabapentin, ketoprofen, lidocaine) commonly included in topical gels for pain management and their potential degradation products. Furthermore, this method was applied to the determination of beyond-use dating of combinations of these drugs prepared in commonly utilized bases (Lipobase, Lipoderm, Pluronic organogel). Gabapentin was determined to be the least stable component in all formulations tested. Measured stability ranged between 7 to 49 days depending on the base and other active drugs present in the formulation. In the absence of gabapentin, baclofen was the next least stable component, lasting for 120 days, regardless of the type of formulating base used. Copyright© by International Journal of Pharmaceutical Compounding, Inc.

  6. An evaluation of the efficacy of a topical gel with Triester Glycerol Oxide (TGO) in the treatment of minor recurrent aphthous stomatitis in a Turkish cohort: A randomized, double-blind, placebo-controlled clinical trial

    PubMed Central

    Ergun, Sertan; Warnakulasuriya, Saman; Namdar-Pekiner, Filiz; Tanyeri, Hakkı

    2017-01-01

    Background Triester glycerol oxide gel (Protefix® Queisser Pharma, Germany) is a new topical agent that has the property of adherence to the oral mucosa by forming a lipid film which protects against mechanical trauma and may help to reduce oral tissue moisture loss and inflammation. The aim of this clinical trial was to determine the efficacy of a topical TGO gel and to also compare it with triamcinolone acetonide pomade in the treatment of minor recurrent aphthous stomatitis. Material and Methods This study was a randomized, double-blind, placebo-controlled clinical trial and 180 patients with the complaint of minor aphthous ulcers were enrolled in this study. The sociodemographic data and clinical characteristics of the ulcer were collected by questionnaire. Ulcer size and pain level measurements were performed and the efficacy indices for ulcer pain and size were calculated at day 0,2,4,6 by the same investigator. Results Significant differences were not detected among the demographics and ulcer histories including age, gender, onset of ulcer, mean healing time, family RAS history and ulcer localization between three groups. The pain score in TGO group was found statistically lower at day 2,4, and 6. Efficacy index and improvement rate of TGO group, regarding pain score, was higher than the other two groups at day 2 and 4. The reduction in ulcer size was statistically higher in TGO group than the other two groups at day 4 and 6. Conclusions Topical application of TGO gel could decrease pain intensity, accelerate ulcer healing without any side effects, utilizing an easy appliable and accessible procedure. Therefore TGO gel could be a well-tolerated, safe, topical therapeutic agent in the clinical practice of RAS treatment. Key words:Topical therapy, triester glycerol oxide, triamcinolone acetonide, minor recurrent aphthous stomatitis. PMID:28160585

  7. Comparison of efficacy of silicone gel, silicone gel sheeting, and topical onion extract including heparin and allantoin for the treatment of postburn hypertrophic scars.

    PubMed

    Karagoz, Huseyin; Yuksel, Fuat; Ulkur, Ersin; Evinc, Rahmi

    2009-12-01

    We compared the efficacy of silicone gel (Scarfade), silicone gel sheet (Epi-Derm), and topical onion extract including heparin and allantoin (Contractubex) for the treatment of hypertrophic scars. Forty-five postburn scars were included in the study. Patients with scars less than 6 months from injury were assigned at random to three groups each containing 15 scars, and their treatment was continued for 6 months. Scars were treated with Scarfade, Epiderm and Contractubex. Scar assessment was performed at the beginning of the treatment, and at the end of the sixth month when the treatment was completed by using the Vancouver scar scale. The difference between before and after treatment scores for each three groups was statistically significant. The difference between Scarfade group and Epi-Derm group was not significant; however, the differences of the other groups (Scarfade-Contractubex, Epiderm-Contractubex) were significant. Silicone products, either in gel or sheet, are superior to Contractubex in the treatment of the hypertrophic scar. The therapist should select the most appropriate agent according to the patient's need and guidelines of these signs.

  8. Cumulative irritation potential among metronidazole gel 1%, metronidazole gel 0.75%, and azelaic acid gel 15%.

    PubMed

    Colón, Luz E; Johnson, Lori A; Gottschalk, Ronald W

    2007-04-01

    Topical therapy for rosacea aims to reduce inflammatory lesions and decrease erythema but can carry side effects such as stinging, pruritus, and burning. Metronidazole and azelaic acid gel 15% are U.S. Food and Drug Administration-approved for the treatment of rosacea. The current study was conducted to assess the cumulative irritation potential of 2 formulations of metronidazole 0.75% gel and 1% gel--and azelaic acid gel 15% over 21 days (N=36). Results of this study demonstrated a significantly greater poten tial for irritation from azelaic acid compared with metronidazole gel 0.75% (P < .0001), which had significantly greater potential for irritation compared with metronidazole gel 1% (P = .0054). Metronidazole gel 1% had a similar profile to white petrolatum.

  9. Topical petrolatum gel alone versus topical silver sulfadiazine with standard gauze dressings for the treatment of superficial partial thickness burns in adults: a randomized controlled trial.

    PubMed

    Genuino, Glenn Angelo S; Baluyut-Angeles, Kathrina Victoria; Espiritu, Andre Paolo T; Lapitan, Marie Carmela M; Buckley, Brian S

    2014-11-01

    Non-extensive superficial partial thickness burns constitute a major proportion of burns. Conventional treatment involves regular changing of absorptive dressings including the application of a topical antimicrobial, commonly silver sulfadiazine. A systematic review has found insufficient evidence to support or refute such antimicrobial prophylaxis. Another review compared silver sulfadiazine dressings with other occlusive and non-antimicrobial dressings and found insufficient evidence to guide practice. Other research has suggested that dressings with petrolatum gel are as effective as silver sulfadiazine. Single-center, randomized, controlled parallel group trial comparing conventional silver sulfadiazine dressings with treatment with petrolatum gel alone. Consenting adults 18-45 years old with superficial partial thickness burns≤10% total body surface area seen within 24h of the injury were randomized to daily dressing either with petrolatum gel without top dressings or conventional silver sulfadiazine treatment with gauze dressings. Primary outcomes were blinded assessment of time to complete re-epithelialization, wound infection or allergic contact dermatitis. Secondary outcomes included assessment of ease, time and pain of dressing changes. 26 patients were randomized to petrolatum and 24 to silver sulfadiazine dressings. Follow up data available for 19 in each group. Mean time to re-epithelialization was 6.2 days (SD 2.8) in the petrolatum group and 7.8 days (SD 2.1) in the silver sulfadiazine group (p=0.050). No wound infection or dermatitis was observed in either group. Scores for adherence to wound, ease of dressing removal and time required to change dressings were significantly better in the petrolatum treatment arm (p<0.01). Petrolatum gel without top dressings may be at least as effective as silver sulfadiazine gauze dressings with regard to time to re-epithelialization, and incidence of infection and allergic contact dermatitis. Petrolatum gel

  10. The Role of Topical Brimonidine Tartrate Gel as a Novel Therapeutic Option for Persistent Facial Erythema Associated with Rosacea.

    PubMed

    Johnson, Andrew William; Johnson, Sandra Marchese

    2015-09-01

    Rosacea is a chronic inflammatory skin condition that commonly presents with persistent facial erythema with or without the coincident presence of flushing, telangiectasias, inflammatory papules or pustules, phymatous changes, or ocular involvement. Patients often present with a constellation of various signs and symptoms of the disease, and an individualized treatment plan should be tailored to a patient's unique clinical presentation. Previously available medications for rosacea have all targeted the inflammatory erythematous papules and pustules frequently associated with the disease, leaving a therapeutic gap for the common manifestation of persistent facial erythema. Brimonidine tartrate 0.33% gel was approved by the US Food and Drug Administration in August 2013 as the first medication available for the topical treatment of persistent facial erythema associated with rosacea. Brimonidine gel is a highly selective α2-adrenergic receptor agonist with potent vasoconstrictive effects, which leads to significant reduction of persistent facial erythema in the majority of patients when applied once daily. Based on large-scale clinical trials and post-marketing reports, brimonidine gel has maintained a good safety profile with a minority of patients experiencing adverse effects from its use, most of which are cutaneous in nature, mild-to-moderate in degree, occur early after initiation of treatment, often resolve spontaneously with continued use, and generally resolve after discontinuation of use. Among the reported adverse effects, two distinct manifestations of worsened erythema have been described. Brimonidine gel can be integrated into a treatment regimen along with concomitant therapies for facial papules and pustules with no increased risk of adverse events with combination therapy. Education about optimal application methods, setting reasonable expectations for treatment, and minimizing inflammation are important factors for the successful use of brimonidine

  11. An evaluation of the efficacy of a topical gel with Triester Glycerol Oxide (TGO) in the treatment of minor recurrent aphthous stomatitis in a Turkish cohort: A randomized, double-blind, placebo-controlled clinical trial.

    PubMed

    Ofluoglu, D; Ergun, S; Warnakulasuriya, S; Namdar-Pekiner, F; Tanyeri, H

    2017-03-01

    Triester glycerol oxide gel (Protefix® Queisser Pharma, Germany) is a new topical agent that has the property of adherence to the oral mucosa by forming a lipid film which protects against mechanical trauma and may help to reduce oral tissue moisture loss and inflammation. The aim of this clinical trial was to determine the efficacy of a topical TGO gel and to also compare it with triamcinolone acetonide pomade in the treatment of minor recurrent aphthous stomatitis. This study was a randomized, double-blind, placebo-controlled clinical trial and 180 patients with the complaint of minor aphthous ulcers were enrolled in this study. The sociodemographic data and clinical characteristics of the ulcer were collected by questionnaire. Ulcer size and pain level measurements were performed and the efficacy indices for ulcer pain and size were calculated at day 0,2,4,6 by the same investigator. Significant differences were not detected among the demographics and ulcer histories including age, gender, onset of ulcer, mean healing time, family RAS history and ulcer localization between three groups. The pain score in TGO group was found statistically lower at day 2,4, and 6. Efficacy index and improvement rate of TGO group, regarding pain score, was higher than the other two groups at day 2 and 4. The reduction in ulcer size was statistically higher in TGO group than the other two groups at day 4 and 6. Topical application of TGO gel could decrease pain intensity, accelerate ulcer healing without any side effects, utilizing an easy appliable and accessible procedure. Therefore TGO gel could be a well-tolerated, safe, topical therapeutic agent in the clinical practice of RAS treatment.

  12. Effectiveness of topical silicone gel and pressure garment therapy for burn scar prevention and management in children: study protocol for a randomised controlled trial.

    PubMed

    Wiseman, Jodie; Simons, Megan; Kimble, Roy; Ware, Robert; McPhail, Steven; Tyack, Zephanie

    2017-02-16

    Abnormal scar development following burn injury can cause substantial physical and psychological distress to children and their families. Common burn scar prevention and management techniques include silicone therapy, pressure garment therapy, or a combination of both. Currently, no definitive, high-quality evidence is available for the effectiveness of topical silicone gel or pressure garment therapy for the prevention and management of burn scars in the paediatric population. Thus, this study aims to determine the effectiveness of these treatments in children. A randomised controlled trial will be conducted at a large tertiary metropolitan children's hospital in Australia. Participants will be randomised to one of three groups: Strataderm® topical silicone gel only, pressure garment therapy only, or combined Strataderm® topical silicone gel and pressure garment therapy. Participants will include 135 children (45 per group) up to 16 years of age who are referred for scar management for a new burn. Children up to 18 years of age will also be recruited following surgery for burn scar reconstruction. Primary outcomes are scar itch intensity and scar thickness. Secondary outcomes include scar characteristics (e.g. colour, pigmentation, pliability, pain), the patient's, caregiver's and therapist's overall opinion of the scar, health service costs, adherence, health-related quality of life, treatment satisfaction and adverse effects. Measures will be completed on up to two sites per person at baseline and 1 week post scar management commencement, 3 months and 6 months post burn, or post burn scar reconstruction. Data will be analysed using descriptive statistics and univariate and multivariate regression analyses. Results of this study will determine the effectiveness of three noninvasive scar interventions in children at risk of, and with, scarring post burn or post reconstruction. Australian New Zealand Clinical Trials Registry, ACTRN12616001100482 . Registered

  13. A novel gel based on an ionic complex from a dendronized polymer and ciprofloxacin: Evaluation of its use for controlled topical drug release.

    PubMed

    García, Mónica C; Cuggino, Julio C; Rosset, Clarisa I; Páez, Paulina L; Strumia, Miriam C; Manzo, Ruben H; Alovero, Fabiana L; Alvarez Igarzabal, Cecilia I; Jimenez-Kairuz, Alvaro F

    2016-12-01

    The development and characterization of a novel, gel-type material based on a dendronized polymer (DP) loaded with ciprofloxacin (CIP), and the evaluation of its possible use for controlled drug release, are presented in this work. DP showed biocompatible and non-toxic behaviors in cultured cells, both of which are considered optimal properties for the design of a final material for biomedical applications. These results were encouraging for the use of the polymer loaded with CIP (as a drug model), under gel form, in the development of a new controlled-release system to be evaluated for topical administration. First, DP-CIP ionic complexes were obtained by an acid-base reaction using the high density of carboxylic acid groups of the DP and the amine groups of the CIP. The complexes obtained in the solid state were broadly characterized using FTIR spectroscopy, XRP diffraction, DSC-TG analysis and optical microscopy techniques. Gels based on the DP-CIP complexes were easily prepared and presented excellent mechanical behaviors. In addition, optimal properties for application on mucosal membranes and skin were achieved due to their high biocompatibility and acute skin non-irritation. Slow and sustained release of CIP toward simulated physiological fluids was observed in the assays (in vitro), attributed to ion exchange phenomenon and to the drug reservoir effect. An in vitro bacterial growth inhibition assay showed significant CIP activity, corresponding to 38 and 58% of that exhibited by a CIP hydrochloride solution at similar CIP concentrations, against Staphylococcus aureus and Pseudomonas aeruginosa, respectively. However, CIP delivery was appropriate, both in terms of magnitude and velocity to allow for a bactericidal effect. In conclusion, the final product showed promising behavior, which could be exploited for the treatment of topical and mucosal opportunistic infections in human or veterinary applications. Copyright © 2016 Elsevier B.V. All rights reserved.

  14. Does topical amethocaine gel reduce pain from heel prick blood sampling in premature infants? A randomized double-blind cross-over controlled study

    PubMed Central

    Patel, Amita; Czerniawski, Barbara; Gray, Shari; Lui, Eric

    2003-01-01

    BACKGROUND: Heel prick blood sampling is the most common painful invasive procedure performed on neonates. Currently, there are no effective ways to provide pain relief from this painful procedure. OBJECTIVE: To assess the efficacy of the topical anesthetic amethocaine 4% gel (Ametop, Smith & Nephew Inc, St Laurent) in reducing the pain of heel prick blood sampling in neonates. METHODS: A randomized, double-blind, placebo controlled, crossover trial was conducted. Neonates between 33 to 37 weeks’ gestational age in their first seven days of life were eligible. Heel prick blood sampling was performed on each participant twice. Each infant was randomly assigned to receive either amethocaine 4% gel or placebo to the heel for the first prick, and then received the alternative agent for the second prick. Prick pain was assessed using both Premature Infant Pain Profile (PIPP) and Neonatal Infant Pain Scale (NIPS). Squeeze pain was assessed by NIPS. RESULTS: Ten babies were recruited. There were no significant differences in the average PIPP and NIPS scores between the treatment and placebo groups for both prick and squeeze pains from heel prick blood sampling. For prick pain, linear-regression showed significant correlation between the PIPP and NIPS scores. No adverse reactions were observed after application of either the active or placebo agents. CONCLUSION: Topical amethocaine 4% gel is not shown to reduce prick and squeeze pains significantly from heel prick blood sampling in neonates between 33 to 37 weeks’ gestational age. Further studies are needed to find ways to provide effective pain relief from this common procedure. PMID:20020001

  15. The Efficacy and Safety of Topical Dapsone Gel, 5% for the Treatment of Acne Vulgaris in Adult Females With Skin of Color.

    PubMed

    Alexis, Andrew F; Burgess, Cheryl; Callender, Valerie D; Herzog, Jo L; Roberts, Wendy E; Schweiger, Eric S; Stockton, Toni C; Gallagher, Conor J

    2016-02-01

    Topical dapsone gel, 5% is approved for treatment of acne vulgaris but has not been studied specifically in women with skin of color (SOC; Fitzpatrick skin types IV, V, or VI). Evaluate safety and efficacy of dapsone gel, 5% applied topically twice daily for 12 weeks in women with SOC. Females with SOC aged 18 years and older with facial acne participated in a multicenter, open-label, single-group, 12-week pilot study of twice-daily monotherapy with dapsone gel, 5%. The investigator-rated 5-point Global Acne Assessment Score (GAAS) was used to assess efficacy. The impact of acne on subjects was assessed using the validated Acne Symptom and Impact Scale (ASIS). The study enrolled and treated 68 women with SOC and facial acne. GAAS decreased significantly from baseline to week 12 (mean, -1.2 [95% CI, -1.4, -1.0]; P<.001), a 39.0% improvement. Overall, 42.9% of subjects were responders based on a GAAS of 0 or 1 at week 12. Subjects also experienced significant reductions in mean total lesions (52% decrease), inflammatory lesions (65%), and comedo counts (41%; all P<.001). Dapsone gel, 5% monotherapy was associated with significant improvement in subject-assessed acne signs (P<.001) and impact on quality of life (QOL; P<.001), based on ASIS. Dapsone gel, 5% used twice daily was well tolerated, with no treatment-related adverse events. The local dermal tolerability scores tended to remain stable or decrease from baseline to week 12. Monotherapy with dapsone gel, 5% administered twice daily was safe and effective for treatment of facial acne in women with SOC. Significant improvement in overall acne severity and both inflammatory lesions and comedones was observed. Further, study subjects reported considerable improvement in both acne signs and impact on QOL.

  16. Dapsone 7.5% Gel: A Review in Acne Vulgaris.

    PubMed

    Al-Salama, Zaina T; Deeks, Emma D

    2017-02-01

    Dapsone 7.5% gel (Aczone ® ) is indicated for the once-daily topical treatment of acne vulgaris in patients aged ≥12 years. Dapsone is a sulfone antibacterial with anti-inflammatory actions, which are thought to be largely responsible for its efficacy in treating acne vulgaris. In two phase III trials of 12 weeks' duration in patients aged ≥12 years with moderate acne vulgaris, once-daily dapsone 7.5% gel reduced acne severity (as per the Global Acne Assessment Score) and lesion counts versus vehicle. The benefits of dapsone 7.5% gel over vehicle were seen as early as week 2 for inflammatory lesion counts, and from week 4 or 8 for other outcomes. Dapsone 7.5% gel was well tolerated, with a low incidence of treatment-related adverse events, with the majority of adverse events being administration-site related and mild or moderate in severity. Thus, dapsone 7.5% gel is an effective and well tolerated option for the topical treatment of acne vulgaris in patients aged ≥12 years, with the convenience of once-daily application.

  17. Topical fluoride (toothpastes, mouthrinses, gels or varnishes) for preventing dental caries in children and adolescents.

    PubMed

    Marinho, V C C; Higgins, J P T; Logan, S; Sheiham, A

    2003-01-01

    Topical fluoride therapy (TFT) in the form of varnish, gel, mouthrinse or toothpaste has been used extensively as a caries-preventive intervention for over three decades. To determine the effectiveness and safety of fluoride varnishes, gels, mouthrinses, and toothpastes in the prevention of dental caries in children and to examine factors potentially modifying their effect. We searched the Cochrane Oral Health Group's Trials Register (May 2000), CENTRAL (The Cochrane Library Issue 2, 2000), MEDLINE (1966 to January 2000), plus several other databases. We handsearched journals, reference lists of articles and contacted selected authors and manufacturers. Randomized or quasi-randomized controlled trials with blind outcome assessment, comparing fluoride varnish, gel, mouthrinse, or toothpaste with placebo or no treatment in children up to 16 years during at least 1 year. The main outcome was caries increment measured by the change in decayed, missing and filled tooth surfaces (D(M)FS). Inclusion decisions, quality assessment and data extraction were duplicated in a random sample of one third of studies, and consensus achieved by discussion or a third party. Authors were contacted for missing data. The primary measure of effect was the prevented fraction (PF) that is the difference in mean caries increments between the treatment and control groups expressed as a percentage of the mean increment in the control group. Random effects meta-analyses were performed where data could be pooled. Potential sources of heterogeneity were examined in random effects metaregression analyses. There were 144 studies included. For the 133 that contributed data for meta-analysis (involving 65,169 children) the D(M)FS pooled prevented fraction estimate was 26% (95% CI, 24% to 29%; p < 0.0001). There was substantial heterogeneity, confirmed statistically (p < 0.0001), but the direction of effect was consistent. The effect of topical fluoride varied according to type of control group used

  18. Topical ketoprofen TDS patch versus diclofenac gel: efficacy and tolerability in benign sport related soft‐tissue injuries

    PubMed Central

    Esparza, Francisco; Cobián, César; Jiménez, José Fernando; García‐Cota, Juan José; Sánchez, Carlos; SETRADE, Antonio Maestro and the working group for the acute pain study of

    2007-01-01

    Objective To compare the ketoprofen TDS patch with diclofenac gel in the treatment of traumatic acute pain in benign sport‐related soft‐tissue injuries. Design 7–14 treatment days, prospective, randomised, open study. Patients Outpatients aged 18–70 years diagnosed for painful benign sport‐related soft‐tissue injury (sprains, strains and contusions within the prior 48 h), randomised to either ketoprofen patch 100 mg once daily (n = 114) or diclofenac gel 2–4 g three times daily (n = 109). Intervention 7–14 days of topical non‐steroidal anti‐inflammatory drugs treatment to assess the pain intensity changes (daily activities and spontaneous at rest) in a daily diary (100‐mm Visual Analogue Scale (VAS)). Main outcome measurement Pain intensity (VAS). Results The ketoprofen patch was not inferior to diclofenac gel in reducing the baseline pain during daily activities (difference of –1.17 mm in favour of ketoprofen patch, 95% CI (–5.86 to 3.52), reducing to the baseline VAS 79%. Ketoprofen patch presented also a higher cure rate (64%) than diclofenac gel (46%) at day 7 (p = 0.004). Patient opinions about the treatment comfort (pharmaceutical shape, application and dosage) were also statistically higher for the ketoprofen patch (>80% of the patients rated as good or excellent the patch removal and skin adherence). Conclusion Ketoprofen patches are effective and safe pain relievers for the treatment of sports injury pain with advantages compared with diclofenac gel. PMID:17138642

  19. Design and Evaluation of Topical Diclofenac Sodium Gel Using Hot Melt Extrusion Technology as a Continuous Manufacturing Process with Kolliphor® P407.

    PubMed

    Pawar, Jaywant; Narkhede, Rajkiran; Amin, Purnima; Tawde, Vaishali

    2017-08-01

    The aim of the present context was to develop and evaluate a Kolliphor® P407-based transdermal gel formulation of diclofenac sodium by hot melt extrusion (HME) technology; central composite design was used to optimize the formulation process. In this study, we have explored first time ever HME as an industrially feasible and continuous manufacturing technology for the manufacturing of gel formulation using Kolliphor® P407 and Kollisolv® PEG400 as a gel base. Diclofenac sodium was used as a model drug. The HME parameters such as feeding rate, screw speed, and barrel temperature were crucial for the semisolid product development, and were optimized after preliminary trials. For the processing of the gel formulation by HME, a modified screw design was used to obtain a uniform product. The obtained product was evaluated for physicochemical characterization such as differential scanning calorimetry (DSC), X-ray diffraction (XRD), pH measurement, rheology, surface tension, and texture profile analysis. Moreover, it was analyzed for general appearance, spreadibility, surface morphology, and drug content. The optimized gel formulation showed homogeneity and transparent film when applied on a glass slide under microscope, pH was 7.02 and uniform drug content of 100.04 ± 2.74 (SD = 3). The DSC and XRD analysis of the HME gel formulation showed complete melting of crystalline API into an amorphous form. The Kolliphor® P407 and Kollisolv® PEG400 formed excellent gel formulation using HME with consistent viscoelastic properties of the product. An improved drug release was found for the HME gel, which showed a 100% drug release than that of a marketed product which showed only 88% of drug release at the end of 12 h. The Flux value of the HME gel was 106 than that of a marketed formulation, which showed only about 60 value, inferring a significant difference (P < 0.05) at the end of 1 h. This study demonstrates a novel application of the hot melt extrusion

  20. The effects of a topical gel containing chitosan, 0,2% chlorhexidine, allantoin and despanthenol on the wound healing process subsequent to impacted lower third molar extraction.

    PubMed

    Madrazo-Jiménez, M; Rodríguez-Caballero, Á; Serrera-Figallo, M-Á; Garrido-Serrano, R; Gutiérrez-Corrales, A; Gutiérrez-Pérez, J-L; Torres-Lagares, D

    2016-11-01

    Despite efforts to prevent postoperative discomfort, there are still many immediate side effects associated with the surgical extraction of impacted lower third molars. Cicatrization is a physiological process through which the loss of integrity of oral mucosa is recovered and damaged tissues are repaired. Bexident Post (ISDIN, Spain) is a topical gel that contains chitosan, 0.2% chlorhexidine, allantoin and dexpanthenol. While this gel has many clinical indications, there are no published clinical trials evaluating its use in impacted mandibular third molar surgery. This study aims to clinically evaluate the efficacy of a gel containing chitosan, 0.2% chlorhexidine, allantoin and dexpanthenol on wound healing and reduction of postoperative side effects and complications after extraction of an impacted mandibular third molar. A split-mouth design study was carried out on a total of 50 bilaterally and symmetrically impacted third molar extractions, which were randomly placed into either a control group (CG=25) or an experimental group (EG=25). Patients were all informed of the purpose of the study and provided written consent. All procedures were carried out by the same dental practitioner, in accordance with standard surgical protocol. A different dental practitioner, unaware of which treatment had been applied, provided follow-up care. The EG applied 10 ml of topical gel composed of chitosan, 0.2% chlorhexidine, allantoin and dexpanthenol to the surgical wound three times a day for 10 days, patients in the CG did not apply any gel. The groups were homogeneous insofar as potentially confounding variables. No significant findings were found regarding postoperative swelling and pain. Neither of the groups displayed poor healing or infectious complications of the wound during the postoperative period. In all the recorded follow-ups (Day 7 p=0.001, and Day 14 p=0.01), the wound's aesthetic appearance was better in the EG. Overall treatment tolerance was satisfactory

  1. The negligible systemic availability of retinoids with multiple and excessive topical application of isotretinoin 0.05% gel (Isotrex) in patients with acne vulgaris.

    PubMed

    Jensen, B K; McGann, L A; Kachevsky, V; Franz, T J

    1991-03-01

    The potential systemic availability of retinoids from topically applied isotretinoin was assessed in 12 men with acne vulgaris. Isotretinoin 0.05% gel was applied to patients at a daily dose of 20 gm (equivalent to 10 mg of isotretinoin) over a 1900 cm2 surface area of skin on the face, back, and chest for 30 days. Blood samples were collected throughout the study and up to 48 hours after the last topical application; they were assayed for isotretinoin, tretinoin, and 4-oxo-isotretinoin by specific high-performance liquid chromatography. Plasma concentrations of isotretinoin, tretinoin, and 4-oxo-isotretinoin were not measurable (less than 20 ng/ml) at any time. Most adverse experiences were cutaneous; a few systemic adverse experiences were judged to be remotely related to topical drug administration. The lack of measurable plasma concentrations of isotretinoin, tretinoin, or 4-oxo-isotretinoin and systemic adverse experiences indicates negligible systemic availability of retinoids even after multiple application of isotretinoin 0.05% gel at doses approximately 12 times greater than normal daily use.

  2. Topical Application of a Bioadhesive Black Raspberry Gel Modulates Gene Expression and Reduces Cyclooxygenase 2 Protein in Human Premalignant Oral Lesions

    PubMed Central

    Mallery, Susan R.; Zwick, Jared C.; Pei, Ping; Tong, Meng; Larsen, Peter E.; Shumway, Brian S.; Lu, Bo; Fields, Henry W.; Mumper, Russell J.; Stoner, Gary D.

    2010-01-01

    Reduced expression of proapoptotic and terminal differentiation genes in conjunction with increased levels of the proinflammatory and angiogenesis-inducing enzymes, cyclooxygenase 2 (COX-2) and inducible nitric oxide synthase (iNOS), correlate with malignant transformation of oral intraepithelial neoplasia (IEN). Accordingly, this study investigated the effects of a 10% (w/w) freeze-dried black raspberry gel on oral IEN histopathology, gene expression profiles, intraepithelial COX-2 and iNOS proteins, and microvascular densities. Our laboratories have shown that freeze-dried black raspberries possess antioxidant properties and also induce keratinocyte apoptosis and terminal differentiation. Oral IEN tissues were hemisected to provide samples for pretreatment diagnoses and establish baseline biochemical and molecular variables. Treatment of the remaining lesional tissue (0.5 g gel applied four times daily for 6 weeks) began 1 week after the initial biopsy. RNA was isolated from snap-frozen IEN lesions for microarray analyses, followed by quantitative reverse transcription-PCR validation. Additional epithelial gene-specific quantitative reverse transcription-PCR analyses facilitated the assessment of target tissue treatment effects. Surface epithelial COX-2 and iNOS protein levels and microvascular densities were determined by image analysis quantified immunohistochemistry. Topical berry gel application uniformly suppressed genes associated with RNA processing, growth factor recycling, and inhibition of apoptosis. Although the majority of participants showed posttreatment decreases in epithelial iNOS and COX-2 proteins, only COX-2 reductions were statistically significant. These data show that berry gel application modulated oral IEN gene expression profiles, ultimately reducing epithelial COX-2 protein. In a patient subset, berry gel application also reduced vascular densities in the superficial connective tissues and induced genes associated with keratinocyte

  3. Intra-cameral level of ganciclovir gel, 0.15% following topical application for cytomegalovirus anterior segment infection: A pilot study.

    PubMed

    Waduthantri, Samanthila; Zhou, Lei; Chee, Soon-Phaik

    2018-01-01

    To investigate the intra-cameral level of ganciclovir following topical application of ganciclovir gel, 0.15% for cytomegalovirus (CMV) anterior segment infection. Non-randomized, prospective, interventional clinical study. Patients with active CMV anterior segment infection seen at Singapore National Eye Centre, confirmed by positive CMV real time PCR (RT-PCR) of the aqueous humor, that had not been treated with any form of ganciclovir in the preceding 1 month were recruited. They were treated with ganciclovir gel, 0.15% 1cc 5 times a day. Following 6 weeks of treatment, CMV load in the aqueous humor was measured using CMV RT-PCR and the ganciclovir drug levels in tears and aqueous humor were measured using high-performance liquid chromatography-mass spectrometry. The clinical features of the disease activity and the central corneal thickness (CCT) were recorded at the baseline and post-treatment. There were 29 eyes of 29 patients, of which 23 eyes had CMV anterior uveitis and 6 eyes had CMV endotheliitis. At the end of week 6, 26 eyes had undetectable CMV titre in the aqueous humor and no anterior chamber (AC) activity. Two patients had an increased CMV titre and increased AC inflammation. Both of these patients were non-compliant with the treatment. One patient had a reduced CMV titre in the aqueous humor with minimal AC inflammation. The mean ganciclovir concentration in the aqueous humor and the tears were 17.4 ± 30.6 ng/ml and 20,420.9 ± 33,120.8 ng/ml respectively. Mean CCT was 552.2 ± 42.3 microns. There was a weak correlation between the ganciclovir concentration in the aqueous humor and CCT (Spearmen's r = + 0.42, p = 0.025). There was no significant correlation between the ganiclovir concentration in the tears and CCT (Spearmen's r = + 0.39, p = 0.11). Ganciclovir levels in the aqueous humor was below the 50% inhibitory dose (ID50) for CMV replication, following topical application of the ganciclovir gel, 0.15%. SingHealth Centralized Institutional

  4. Intra-cameral level of ganciclovir gel, 0.15% following topical application for cytomegalovirus anterior segment infection: A pilot study

    PubMed Central

    Zhou, Lei; Chee, Soon-Phaik

    2018-01-01

    Purpose To investigate the intra-cameral level of ganciclovir following topical application of ganciclovir gel, 0.15% for cytomegalovirus (CMV) anterior segment infection. Design Non-randomized, prospective, interventional clinical study. Methods Patients with active CMV anterior segment infection seen at Singapore National Eye Centre, confirmed by positive CMV real time PCR (RT-PCR) of the aqueous humor, that had not been treated with any form of ganciclovir in the preceding 1 month were recruited. They were treated with ganciclovir gel, 0.15% 1cc 5 times a day. Following 6 weeks of treatment, CMV load in the aqueous humor was measured using CMV RT-PCR and the ganciclovir drug levels in tears and aqueous humor were measured using high-performance liquid chromatography-mass spectrometry. The clinical features of the disease activity and the central corneal thickness (CCT) were recorded at the baseline and post-treatment. Results There were 29 eyes of 29 patients, of which 23 eyes had CMV anterior uveitis and 6 eyes had CMV endotheliitis. At the end of week 6, 26 eyes had undetectable CMV titre in the aqueous humor and no anterior chamber (AC) activity. Two patients had an increased CMV titre and increased AC inflammation. Both of these patients were non-compliant with the treatment. One patient had a reduced CMV titre in the aqueous humor with minimal AC inflammation. The mean ganciclovir concentration in the aqueous humor and the tears were 17.4 ± 30.6 ng/ml and 20,420.9 ± 33,120.8 ng/ml respectively. Mean CCT was 552.2 ± 42.3 microns. There was a weak correlation between the ganciclovir concentration in the aqueous humor and CCT (Spearmen's r = + 0.42, p = 0.025). There was no significant correlation between the ganiclovir concentration in the tears and CCT (Spearmen's r = + 0.39, p = 0.11). Conclusion Ganciclovir levels in the aqueous humor was below the 50% inhibitory dose (ID50) for CMV replication, following topical application of the ganciclovir gel, 0

  5. Topical tenofovir protects against vaginal simian HIV infection in macaques coinfected with Chlamydia trachomatis and Trichomonas vaginalis.

    PubMed

    Makarova, Natalia; Henning, Tara; Taylor, Andrew; Dinh, Chuong; Lipscomb, Jonathan; Aubert, Rachael; Hanson, Debra; Phillips, Christi; Papp, John; Mitchell, James; McNicholl, Janet; Garcia-Lerma, Gerardo J; Heneine, Walid; Kersh, Ellen; Dobard, Charles

    2017-03-27

    Chlamydia trachomatis and Trichomonas vaginalis, two prevalent sexually transmitted infections, are known to increase HIV risk in women and could potentially diminish preexposure prophylaxis efficacy, particularly for topical interventions that rely on local protection. We investigated in macaques whether coinfection with Chlamydia trachomatis/Trichomonas vaginalis reduces protection by vaginal tenofovir (TFV) gel. Vaginal TFV gel dosing previously shown to provide 100 or 74% protection when applied either 30 min or 3 days before simian HIV(SHIV) challenge was assessed in pigtailed macaques coinfected with Chlamydia trachomatis/Trichomonas vaginalis and challenged twice weekly with SHIV162p3 for up to 10 weeks (two menstrual cycles). Three groups of six macaques received either placebo or 1% TFV gel 30 min or 3 days before each SHIV challenge. We additionally assessed TFV and TFV diphosphate concentrations in plasma and vaginal tissues in Chlamydia trachomatis/Trichomonas vaginalis coinfected (n = 4) and uninfected (n = 4) macaques. Chlamydia trachomatis/Trichomonas vaginalis coinfections were maintained during the SHIV challenge period. All macaques that received placebo gel were SHIV infected after a median of seven challenges (one menstrual cycle). In contrast, no infections were observed in macaques treated with TFV gel 30 min before SHIV challenge (P < 0.001). Efficacy was reduced to 60% when TFV gel was applied 3 days before SHIV challenge (P = 0.07). Plasma TFV and TFV diphosphate concentrations in tissues and vaginal lymphocytes were significantly higher in Chlamydia trachomatis/Trichomonas vaginalis coinfected compared with Chlamydia trachomatis/Trichomonas vaginalis uninfected macaques. Our findings in this model suggest that Chlamydia trachomatis/Trichomonas vaginalis coinfection may have little or no impact on the efficacy of highly effective topical TFV modalities and highlight a significant modulation of TFV pharmacokinetics.

  6. The effects of a topical gel containing chitosan, 0,2% chlorhexidine, allantoin and despanthenol on the wound healing process subsequent to impacted lower third molar extraction

    PubMed Central

    Madrazo-Jiménez, Marta; Rodríguez-Caballero, Ángela; Serrera-Figallo, María-Ángeles; Garrido-Serrano, Roberto; Gutiérrez-Corrales, Aida; Gutiérrez-Pérez, José-Luis

    2016-01-01

    Background Despite efforts to prevent postoperative discomfort, there are still many immediate side effects associated with the surgical extraction of impacted lower third molars. Cicatrization is a physiological process through which the loss of integrity of oral mucosa is recovered and damaged tissues are repaired. Bexident Post (ISDIN, Spain) is a topical gel that contains chitosan, 0.2% chlorhexidine, allantoin and dexpanthenol. While this gel has many clinical indications, there are no published clinical trials evaluating its use in impacted mandibular third molar surgery. This study aims to clinically evaluate the efficacy of a gel containing chitosan, 0.2% chlorhexidine, allantoin and dexpanthenol on wound healing and reduction of postoperative side effects and complications after extraction of an impacted mandibular third molar. Material and Methods A split-mouth design study was carried out on a total of 50 bilaterally and symmetrically impacted third molar extractions, which were randomly placed into either a control group (CG=25) or an experimental group (EG=25). Patients were all informed of the purpose of the study and provided written consent. All procedures were carried out by the same dental practitioner, in accordance with standard surgical protocol. A different dental practitioner, unaware of which treatment had been applied, provided follow-up care. The EG applied 10 ml of topical gel composed of chitosan, 0.2% chlorhexidine, allantoin and dexpanthenol to the surgical wound three times a day for 10 days, patients in the CG did not apply any gel. Results The groups were homogeneous insofar as potentially confounding variables. No significant findings were found regarding postoperative swelling and pain. Neither of the groups displayed poor healing or infectious complications of the wound during the postoperative period. In all the recorded follow-ups (Day 7 p=0.001, and Day 14 p=0.01), the wound’s aesthetic appearance was better in the EG

  7. TOPICAL TENOFOVIR, A MICROBICIDE EFFECTIVE AGAINST HIV, INHIBITS HERPES SIMPLEX VIRUS-2 REPLICATION

    PubMed Central

    Andrei, Graciela; Lisco, Andrea; Vanpouille, Christophe; Introini, Andrea; Balestra, Emanuela; van den Oord, Joost; Cihlar, Tomas; Perno, Carlo-Federico; Snoeck, Robert; Margolis, Leonid; Balzarini, Jan

    2011-01-01

    SUMMARY The HIV reverse transcriptase inhibitor tenofovir, was recently formulated into a vaginal gel for use as a microbicide. In human trials, a 1% tenofovir gel inhibited HIV sexual transmission by 39% and surprisingly herpes simplex virus-2 (HSV-2) transmission by 51%. We demonstrate that the concentration achieved intravaginally with a 1% tenofovir topical gel has direct anti-herpetic activity. Tenofovir inhibits the replication of HSV clinical isolates in human embryonic fibroblasts, keratinocytes, and organotypic epithelial 3D-rafts, decreases HSV replication in human lymphoid and cervical tissues ex vivo, and delays HSV-induced lesions and death of topically treated HSV-infected mice. The active tenofovir metabolite inhibits HSV DNA-polymerase and HIV reverse transcriptase. Tenofovir must be topically administered to achieve concentrations, which are higher than systemic levels after oral treatment, that exert these dual antiviral effects. These findings indicate that a single topical treatment, like tenofovir, can inhibit the transmission of HIV and its co-pathogens. PMID:22018238

  8. 48 CFR 1535.007 - Solicitations.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 48 Federal Acquisition Regulations System 6 2012-10-01 2012-10-01 false Solicitations. 1535.007 Section 1535.007 Federal Acquisition Regulations System ENVIRONMENTAL PROTECTION AGENCY SPECIAL CATEGORIES OF CONTRACTING RESEARCH AND DEVELOPMENT CONTRACTING 1535.007 Solicitations. (a) Contracting officers...

  9. 48 CFR 1535.007 - Solicitations.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 48 Federal Acquisition Regulations System 6 2011-10-01 2011-10-01 false Solicitations. 1535.007 Section 1535.007 Federal Acquisition Regulations System ENVIRONMENTAL PROTECTION AGENCY SPECIAL CATEGORIES OF CONTRACTING RESEARCH AND DEVELOPMENT CONTRACTING 1535.007 Solicitations. (a) Contracting officers...

  10. 48 CFR 1535.007 - Solicitations.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 48 Federal Acquisition Regulations System 6 2014-10-01 2014-10-01 false Solicitations. 1535.007 Section 1535.007 Federal Acquisition Regulations System ENVIRONMENTAL PROTECTION AGENCY SPECIAL CATEGORIES OF CONTRACTING RESEARCH AND DEVELOPMENT CONTRACTING 1535.007 Solicitations. (a) Contracting officers...

  11. 48 CFR 1535.007 - Solicitations.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 48 Federal Acquisition Regulations System 6 2013-10-01 2013-10-01 false Solicitations. 1535.007 Section 1535.007 Federal Acquisition Regulations System ENVIRONMENTAL PROTECTION AGENCY SPECIAL CATEGORIES OF CONTRACTING RESEARCH AND DEVELOPMENT CONTRACTING 1535.007 Solicitations. (a) Contracting officers...

  12. Electrical transport and thermoelectric properties of Ni-doped perovskite-type YCo1-x NixO3 (0 <= x <= 0.07) prepared by sol-gel process

    NASA Astrophysics Data System (ADS)

    Liu, Yi; Li, Hai-Jin; Zhang, Qing; Li, Yong; Liu, Hou-Tong

    2013-05-01

    Electrical transport and thermoelectric properties of Ni-doped YCo1-xNixO3(0 <= x <= 0.07), prepared by using the sol-gel process, are investigated in a temperature range from 100 to 780 K. The results show that with the increase of Ni doping content, the values of DC resistivity of YCo1-xNixO3 decrease, but carrier concentration increases. The temperature dependences of the resistivity for YCo1-xNixO3 are found to follow a relation of ln ρ ∝ 1/T in a low-temperature range (LTR) (T < ~ 304 K for x = 0; ~ 230 K < T < ~ 500 K for x = 0.02, 0.05, and 0.07) and high-temperature range (HTR) (T > ~ 655 K for all compounds), respectively. The estimated apparent activation energies for conduction Ea1 in LRT and Ea2 in HTR are both found to decrease monotonically with doping content increasing. At very low temperatures (T < ~230 K), Mott's law is observed for YCo1—xNixO3 (x >= 0.02), indicating that considerable localized states form in the heavy doping compounds. Although the Seebeck coefficient of the compound decreases after Ni doping, the power factor of YCo1-xNixO3 is enhanced remarkably in a temperature range from 300 to 740 K, i.e., a 6-fold increase is achieved at 500 K for YCo0.98Ni0.02O3, indicating that the high-temperature thermoelectric property of YCoO3 can be improved by partial substitution of Ni for Co.

  13. Tolerability of clindamycin/tretinoin gel vs. tretinoin microsphere gel and adapalene gel.

    PubMed

    Leyden, James; Wortzman, Mitchell; Baldwin, Edward K

    2009-04-01

    Newer agents and formulations seek to improve the tolerability of topical retinoid therapy. Recently, a gel containing crystalline clindamycin 1.2% and tretinoin 0.025% (CLIN/RA) was approved by the U.S. Food and Drug Administration (FDA) for the treatment of treating mild-to-moderate acne. This single-center, randomized, evaluator-blind phase 1 study compared the tolerability of CLIN/RA to 0.1% tretinoin gel or 0.1% adapalene gel. Forty-five patients applied CLIN/RA once daily to one side of their face every day for 21 days. Patients were randomized to either tretinoin 0.1% (n = 23) or adapalene 0.1% (n = 22) on the contralateral side. A clinical evaluator assessed degree of erythema and scaling; patients provided subjective evaluations of burning, stinging, and itching. CLIN/RA was significantly better tolerated than was 0.1% tretinoin gel, as evidenced by significantly reduced erythema (P < 0.04), scaling (P < 0.03), itching (P < 0.02), burning (P < 0.03) and stinging (P < 0.04). A trend for greater erythema, scaling, and subjective discomfort for 0.1% adapalene gel compared to CLIN/RA was also evident.

  14. Clinical Comparison: Fast-Acting and Traditional Topical Dental Anesthetic

    PubMed Central

    DiMarco, Arthur C.; Wetmore, Ann O'Kelley

    2016-01-01

    A randomized, nonblinded clinical trial compared the effectiveness of an application method of a fast-acting refrigerant topical agent to a 20% benzocaine gel topical. In a split-mouth design, right and left anterior middle superior alveolar injections (N = 30) were administered with a 27-gauge needle at least 24 hours apart with preinjection topicals. Using a cotton-tipped applicator, a refrigerant topical was applied for 5 seconds and 20% benzocaine gel for 2 minutes on opposite sides at 2 separate appointments. Subjects self-reported pain perception after each injection using a visual analog scale (VAS). The mean VAS ratings demonstrated no significant difference between the 5-second application of the refrigerant (M = 16.2, SD = 17.7) and the 2-minute application of 20% benzocaine topical gel anesthetic (M = 17.9, SD = 18.2). Fifty-seven percent of the subjects reported greater pain reduction with the refrigerant, 33% reported greater pain reduction with 20% benzocaine, and 10% reported no difference. Results suggest the described method of application of a refrigerant as an oral topical anesthetic has a faster onset and provides similar benefit in pain reduction compared with 20% benzocaine gel. The refrigerant was easy to accomplish and well received by subjects, indicating potential for routine use in dentistry. PMID:27269661

  15. Clinical Comparison: Fast-Acting and Traditional Topical Dental Anesthetic.

    PubMed

    DiMarco, Arthur C; Wetmore, Ann O'Kelley

    2016-01-01

    A randomized, nonblinded clinical trial compared the effectiveness of an application method of a fast-acting refrigerant topical agent to a 20% benzocaine gel topical. In a split-mouth design, right and left anterior middle superior alveolar injections (N = 30) were administered with a 27-gauge needle at least 24 hours apart with preinjection topicals. Using a cotton-tipped applicator, a refrigerant topical was applied for 5 seconds and 20% benzocaine gel for 2 minutes on opposite sides at 2 separate appointments. Subjects self-reported pain perception after each injection using a visual analog scale (VAS). The mean VAS ratings demonstrated no significant difference between the 5-second application of the refrigerant (M = 16.2, SD = 17.7) and the 2-minute application of 20% benzocaine topical gel anesthetic (M = 17.9, SD = 18.2). Fifty-seven percent of the subjects reported greater pain reduction with the refrigerant, 33% reported greater pain reduction with 20% benzocaine, and 10% reported no difference. Results suggest the described method of application of a refrigerant as an oral topical anesthetic has a faster onset and provides similar benefit in pain reduction compared with 20% benzocaine gel. The refrigerant was easy to accomplish and well received by subjects, indicating potential for routine use in dentistry.

  16. Poloxamer-Based Thermoreversible Gel for Topical Delivery of Emodin: Influence of P407 and P188 on Solubility of Emodin and Its Application in Cellular Activity Screening.

    PubMed

    Ban, Eunmi; Park, Mijung; Jeong, Seonghee; Kwon, Taekhyun; Kim, Eun-Hee; Jung, Kiwon; Kim, Aeri

    2017-02-07

    Emodin is a component in a Chinese herb, Rheum officinale Baill, traditionally used for diabetes and anticancer. Its poor solubility is one of the major challenges to pharmaceutical scientists. We previously reported on thermoreversible gel formulations based on poloxamer for the topical delivery of emodin. The present study was to understand the effect of poloxamer type on emodin solubility and its application in cellular activity screening. Various gel formulations composed of poloxamer 407 (P407), poloxamer 188 (P188) and PEG400 were prepared and evaluated. Major evaluation parameters were the gelation temperature (Tgel) and solubility of emodin. The emodin solubility increased with increasing poloxamer concentration and the Tgel was modulated by the proper combination of P407. In particular, this study showed that the amount of P407 in thermoreversible poloxamer gel (PG) was the dominant factor in enhancing solubility and P188 was effective at fixing gelation temperature in the desired range. A thermoreversible emodin PG was selected as the proper composition with the liquid state at room temperature and gel state at body temperature. The gel showed the solubility enhancement of emodin at least 100-fold compared to 10% ethanol or water. The thermoreversible formulation was applied for in vitro cellular activity screening in the human dermal fibroblast cell line and DLD-1 colon cancer cell line after dilution with cell culture media. The thermoreversible gel formulation remained as a clear solution in the microplate, which allowed reliable cellular activity screening. In contrast, emodin solution in ethanol or DMSO showed precipitation at the corresponding emodin concentration, complicating data interpretation. In conclusion, the gel formulation is proposed as a useful prototype topical formulation for testing emodin in vivo as well as in vitro.

  17. Finasteride topical delivery systems for androgenetic alopecia.

    PubMed

    Khan, Muhammad Zia Ullah; Khan, Shujaat Ali; Ubaid, Muhammad; Shah, Aamna; Kousar, Rozina; Murtaza, Ghulam

    2018-01-23

    Androgenetic alopecia, generally recognized as male pattern baldness, is a gradually developing medical and physiological change, which is manifested by continuous hair-loss from scalp. Finasteride (4-aza-3-oxosteroid) is a potent anti-baldness compound that selectively and competitively inhibits the 5α-reductase isoenzymes. Prolonged oral use of finasteride leads to the emergence of sexual disorders including decrease in libido, gynecomastia, erectile dysfunction, ejaculation disorder, orgasm disorders and mood disturbances. Since, hair follicles widely home in 5α-reductase, topical formulations of finasteride in comparison to its oral formulations are expected to potentially reduce its systemic adverse effects. The analysis of literature has revealed some delivery systems developed for the enhanced and localized penetration of finasteride into the skin. These finasteride delivery systems include polymersomes, vesicular nanocarriers, vesicular ethosomal carriers, liposomes and niosomes, liquid crystalline nanoparticles, topical solutions and gels. The aim of this review article is to briefly amass all literature on topical delivery of finasteride to elaborate best dosage form, i.e. formulation having maximum permeation rate. This study will serve as a future perspective regarding topical delivery of finasteride. The literature analysis has exhibited that most of the previous investigators have used propylene glycol in their finasteride-loaded topical formulations, while poloxamer P407, monoolein, transcutol P and choline was used in few formulations. Moreover among all drug delivery systems, finasteride liposomal gel system consisting of 2% methyl cellulose and gel system containing poloxamer P407 exhibited the highest flux with a value of 28.4 ± 1.3 µg/cm2h and 23.1 ± 1.4 µg/cm2h, respectively. Several topical drug delivery techniques such as topical microneedles, aerosol foams, nanoemulsions, microsponges, and emulsifier free formulations, fullerenes

  18. The effect of clove and benzocaine versus placebo as topical anesthetics.

    PubMed

    Alqareer, Athbi; Alyahya, Asma; Andersson, Lars

    2006-11-01

    The purpose of this study was to examine whether the natural herb clove can replace benzocaine as a topical anesthetic. Topical agents were applied to the maxillary canine buccal mucosa of 73 adult volunteers. Four substances were tested in the study: (1) homemade clove gel, (2) benzocaine 20% gel, (3) placebo that resembles clove and (4) a placebo that resembled benzocaine. After 5 min of material application in a randomized, subject-blinded manner, each participant received two needle sticks. Pain response was registered using a 100 mm visual analogue pain scale. Both clove and benzocaine gels had significantly lower mean pain scores than placebos (p=0.005). No significant difference was observed between clove and benzocaine regarding pain scores. Clove gel might possess a potential to replace benzocaine as a topical agent before needle insertion.

  19. Comparative clinical trial of topical anesthetic agents in cataract surgery: lidocaine 2% gel, bupivacaine 0.5% drops, and benoxinate 0.4% drops.

    PubMed

    Soliman, Mahmoud M; Macky, Tamer A; Samir, M Khaled

    2004-08-01

    To assess the efficacy of lidocaine gel, bupivacaine drops, and benoxinate drops as topical anesthetic agents in cataract surgery. Kasr El-Aini Hospital, Cairo University, Cairo, Egypt. This prospective randomized study comprised 90 patients scheduled for routine cataract extraction. Patients were randomized into 3 groups of 30 each based on which anesthetic agent they received: lidocaine 2% gel, bupivacaine 0.5% drops, or benoxinate 0.4% drops. Subjective pain at application of the agent and intraoperatively was quantified by the patients using a verbal pain score (VPS) scale from 0 to 10. The duration of discomfort at application, duration of surgery, rate of supplemental sub-Tenon's anesthesia, and complications were recorded. The mean VPS at application was 2.97, 1.53, and 1.03 in the lidocaine, bupivacaine, and benoxinate groups, respectively; the VPS in the lidocaine group was statistically significantly higher than in the other 2 groups (P<.001). The mean duration of pain at application was 25 seconds, 14 seconds, and 6 seconds in the lidocaine, bupivacaine, and benoxinate groups, respectively, and was statistically significantly higher in the lidocaine group (P<.001). The mean VPS during surgery was 1.6, 4.1, and 7.1 in the lidocaine, bupivacaine, and benoxinate groups; the lidocaine group had a statistically significantly lower mean VPS than the other 2 groups (P<.001). The incidence of supplemental sub-Tenon's injection was 3.3%, 10.0%, and 73.3%, respectively, and was statistically significantly lower in the lidocaine and bupivacaine groups than in the benoxinate group (P<.001). The patients' overall satisfaction was statistically significantly higher in the lidocaine and bupivacaine groups than in the benoxinate group (93.3%, 83.3%, and 33.3%, respectively) (P<.001). Three patients in the lidocaine group had corneal haze at the time of surgery, which was not statistically significant (P>.1). Lidocaine gel was a better topical anesthetic agent than

  20. Diclofenac Topical (osteoarthritis pain)

    MedlinePlus

    ... gel (Voltaren) is used to relieve pain from osteoarthritis (arthritis caused by a breakdown of the lining ... Diclofenac topical liquid (Pennsaid) is used to relieve osteoarthritis pain in the knees. Diclofenac is in a ...

  1. Topical Prophylaxis for HIV Prevention in Women: Becoming a Reality

    PubMed Central

    Verma, Natasha A.; Lee, Anna C.; Herold, Betsy C.

    2011-01-01

    Strategies to protect against sexual transmission of HIV include the development of products formulated for topical application, which limit the toxicities associated with systemic oral pre-exposure prophylaxis. Following several clinical trial failures, attention is now focused on antiretroviral (ARV) agents. Highly potent ARV topical formulations provide a female-controlled, targeted, and feasible option for HIV prevention. A recently completed tenofovir gel trial was the first to demonstrate significant protection against HIV acquisition. Topical ARVs have the advantage of delivering high concentration of drug at the site of transmission of HIV, with low systemic absorption. Sustained-release formulations, such as intravaginal rings, will likely improve adherence and can be designed to provide controlled and continuous delivery of ARV combinations. Further studies to test alternative dosing strategies and pharmacokinetic/pharmacodynamic relationships in the genital tract will provide valuable information as the field strives to improve upon the promising tenofovir gel trial results. PMID:21424725

  2. Thermoreversible Gel Formulations Containing Sodium Lauryl Sulfate or n-Lauroylsarcosine as Potential Topical Microbicides against Sexually Transmitted Diseases

    PubMed Central

    Roy, Sylvie; Gourde, Pierrette; Piret, Jocelyne; Désormeaux, André; Lamontagne, Julie; Haineault, Caroline; Omar, Rabeea F.; Bergeron, Michel G.

    2001-01-01

    The microbicidal efficacies of two anionic surfactants, sodium lauryl sulfate (SLS) and n-lauroylsarcosine (LS), were evaluated in cultured cells and in a murine model of herpes simplex type 2 (HSV-2) intravaginal infection. In vitro studies showed that SLS and LS were potent inhibitors of the infectivity of HSV-2 strain 333. The concentrations of SLS which inhibit viral infectivity by 50% (50% inhibitory dose) and 90% (90% inhibitory dose) were 32.67 and 46.53 μM, respectively, whereas the corresponding values for LS were 141.76 and 225.30 μM. In addition, intravaginal pretreatment of mice with thermoreversible gel formulations containing 2.5% SLS or 2.5% LS prior to the inoculation of HSV-2 strain 333 completely prevented the development of genital herpetic lesions and the lethality associated with infection. Of prime interest, no infectious virus could be detected in mouse vaginal mucosa. Both formulations still provided significant protection when viral challenge was delayed until 1 h after pretreatment. Finally, intravaginal application of gel formulations containing 2.5% SLS or 2.5% LS once daily for 14 days to rabbits did not induce significant irritations to the genital mucosa, as demonstrated from macroscopic and histopathologic examinations. These results suggest that thermoreversible gel formulations containing SLS or LS could represent potent and safe topical microbicides for the prevention of HSV-2 and possibly other sexually transmitted pathogens, including human immunodeficiency virus. PMID:11353610

  3. Efficacy and safety of topical SR-T100 gel in treating actinic keratosis in Taiwan: A Phase III randomized double-blind vehicle-controlled parallel trial.

    PubMed

    Yang, Chao-Chun; Wong, Tak-Wah; Lee, Chih-Hung; Hong, Chien-Hui; Chang, Chung-Hsing; Lai, Feng-Jie; Lin, Shang-Hung; Chi, Ching-Chi; Lin, Tzu-Kai; Yen, Hsi; Wu, Chin-Han; Sheu, Hamm-Ming; Lan, Cheng-Che E

    2018-06-01

    Currently available topical treatments for actinic keratosis (AK) are associated with substantial side-effects. To evaluate the efficacy and safety of topical SR-T100 gel in treating AK. A multicenter, randomized, double-blinded phase III trial was conducted. Patients with at least two clinically visible AK were enrolled and a punch biopsy was performed on one of the AK to confirm the diagnosis. This study consisted of up to 16-week treatment and 8-week post-treatment periods. Medication was applied daily with occlusive dressing. 123 subjects were recruited and 113 were randomized. 76 subjects were in the SR-T100 and 37 in the vehicle arms. In SR-T100 and vehicle groups, 32.39% and 17.14% of subjects achieved complete clearance, respectively. For 75% partial clearance of lesions, 71.83% and 37.1% of subjects achieved this goal in SR-T100 and vehicle group, respectively. When comparing SR-T100 to vehicle, the odds ratio of complete clearance was 2.14 (p = 0.111), and odds ratio of partial clearance was 4.36 (p < 0.001). Severe local reactions were reported by only one subject using SR-T100. The imitation of the study was that not all the treated AK lesions were confirmed by histopathology. The diagnostic uncertainty may contribute to the high partial clearance rate in the vehicle group since the clinical-diagnosed AK showed higher clearance rate compared to histopathology-confirmed AK. The use of occlusive dressing was another possible explanation for high placebo effects. The results suggested that topical SR-T100 gel may be an effective and safe treatment for field therapy of AK. Copyright © 2018 Japanese Society for Investigative Dermatology. Published by Elsevier B.V. All rights reserved.

  4. Topical fluoride for caries prevention

    PubMed Central

    Weyant, Robert J.; Tracy, Sharon L.; Anselmo, Theresa (Tracy); Beltrán-Aguilar, Eugenio D.; Donly, Kevin J.; Frese, William A.; Hujoel, Philippe P.; Iafolla, Timothy; Kohn, William; Kumar, Jayanth; Levy, Steven M.; Tinanoff, Norman; Wright, J. Timothy; Zero, Domenick; Aravamudhan, Krishna; Frantsve-Hawley, Julie; Meyer, Daniel M.

    2015-01-01

    Background A panel of experts convened by the American Dental Association (ADA) Council on Scientific Affairs presents evidence-based clinical recommendations regarding professionally applied and prescription-strength, home-use topical fluoride agents for caries prevention. These recommendations are an update of the 2006 ADA recommendations regarding professionally applied topical fluoride and were developed by using a new process that includes conducting a systematic review of primary studies. Types of Studies Reviewed The authors conducted a search of MEDLINE and the Cochrane Library for clinical trials of professionally applied and prescription-strength topical fluoride agents—including mouthrinses, varnishes, gels, foams and pastes—with caries increment outcomes published in English through October 2012. Results The panel included 71 trials from 82 articles in its review and assessed the efficacy of various topical fluoride caries-preventive agents. The panel makes recommendations for further research. Practical Implications The panel recommends the following for people at risk of developing dental caries: 2.26 percent fluoride varnish or 1.23 percent fluoride (acidulated phosphate fluoride) gel, or a prescription-strength, home-use 0.5 percent fluoride gel or paste or 0.09 percent fluoride mouthrinse for patients 6 years or older. Only 2.26 percent fluoride varnish is recommended for children younger than 6 years. The strengths of the recommendations for the recommended products varied from “in favor” to “expert opinion for.” As part of the evidence-based approach to care, these clinical recommendations should be integrated with the practitioner's professional judgment and the patient's needs and preferences. PMID:24177407

  5. Efficacy of nano- and microemulsion-based topical gels in delivery of ibuprofen: an in vivo study.

    PubMed

    Azizi, Mosayeb; Esmaeili, Fariba; Partoazar, Alireza; Ejtemaei Mehr, Shahram; Amani, Amir

    2017-03-01

    Nanoemulsion has shown many advantages in drug delivery systems. In this study, for the first time, analgesic and anti-inflammatory properties of a nanomelusion of almond oil with and without ibuprofen was compared with corresponding microemulsion and commercial topical gel of the drug using formalin and carrageenan tests, respectively. Almond oil (oil phase) was mixed with Tween 80 and Span 80 (surfactants), and ethanol (co-surfactant) and them distilled water (aqueous phase) was then added to the mixture at once. Prepared nanoemulsions were pre-emulsified into a 100 ml beaker using magnet/stirrer (1000 rpm). Then, using a probe ultrasonicator (Hielscher UP400s, Hielscher, Ringwood, NJ) the nanoemulsions were formed. The optimised nanoemulsion formulation containing 2.5% ibuprofen, showed improved analgesic and anti-inflammatory effects compared with commercial product and corresponding microemulsion product containing 5% ibuprofen (i.e. twice the content of ibuprofen in the nanoemulsion) in vivo. The nanoemulsion preparation showed superior analgesic activities during chronic phase. Also, it decreased the inflammation from the first hour, while the microemulsion and the commercial product started to show their anti-inflammatory effects after 2 and 3 h, respectively. Our finding suggests that the size of the emulsion particles must be considered as an important factor in topical drug delivery systems.

  6. Liposomal lidocaine gel for topical use at the oral mucosa: characterization, in vitro assays and in vivo anesthetic efficacy in humans.

    PubMed

    Franz-Montan, Michelle; Baroni, Daniela; Brunetto, Giovana; Sobral, Viviane Roberta Vieira; da Silva, Camila Morais Gonçalves; Venâncio, Paulo; Zago, Patricia Wiziack; Cereda, Cintia Maria Saia; Volpato, Maria Cristina; de Araújo, Daniele Ribeiro; de Paula, Eneida; Groppo, Francisco Carlos

    2015-03-01

    To characterize liposomal-lidocaine formulations for topical use on oral mucosa and to compare their in vitro permeation and in vivo anesthetic efficacy with commercially available lidocaine formulations. Large unilamellar liposomes (400 nm) containing lidocaine were prepared using phosphatidylcholine, cholesterol, and α-tocoferol (4:3:0.07, w:w:w) and were characterized in terms of membrane/water partition coefficient, encapsulation efficiency, size, polydispersity, zeta potential, and in vitro release. In vitro permeation across pig palatal mucosa and in vivo topical anesthetic efficacy on the palatal mucosa in healthy volunteers (double-blinded cross-over, placebo controlled study) were performed. The following formulations were tested: liposome-encapsulated 5% lidocaine (Liposome-Lido5); liposome-encapsulated 2.5% lidocaine (Liposome-Lido2.5); 5% lidocaine ointment (Xylocaina®), and eutectic mixture of lidocaine and prilocaine 2.5% (EMLA®). The Liposome-Lido5 and EMLA showed the best in vitro permeation parameters (flux and permeability coefficient) in comparison with Xylocaina and placebo groups, as well as the best in vivo topical anesthetic efficacy. We successfully developed and characterized a liposome encapsulated 5% lidocaine gel. It could be considered an option to other topical anesthetic agents for oral mucosa.

  7. Designing preclinical perceptibility measures to evaluate topical vaginal gel formulations: relating user sensory perceptions and experiences to formulation properties.

    PubMed

    Morrow, Kathleen M; Fava, Joseph L; Rosen, Rochelle K; Vargas, Sara; Shaw, Julia G; Kojic, E Milu; Kiser, Patrick F; Friend, David R; Katz, David F

    2014-01-01

    Abstract The effectiveness of any biomedical prevention technology relies on both biological efficacy and behavioral adherence. Microbicide trials have been hampered by low adherence, limiting the ability to draw meaningful conclusions about product effectiveness. Central to this problem may be an inadequate conceptualization of how product properties themselves impact user experience and adherence. Our goal is to expand the current microbicide development framework to include product "perceptibility," the objective measurement of user sensory perceptions (i.e., sensations) and experiences of formulation performance during use. For vaginal gels, a set of biophysical properties, including rheological properties and measures of spreading and retention, may critically impact user experiences. Project LINK sought to characterize the user experience in this regard, and to validate measures of user sensory perceptions and experiences (USPEs) using four prototype topical vaginal gel formulations designed for pericoital use. Perceptibility scales captured a range of USPEs during the product application process (five scales), ambulation after product insertion (six scales), and during sexual activity (eight scales). Comparative statistical analyses provided empirical support for hypothesized relationships between gel properties, spreading performance, and the user experience. Project LINK provides preliminary evidence for the utility of evaluating USPEs, introducing a paradigm shift in the field of microbicide formulation design. We propose that these user sensory perceptions and experiences initiate cognitive processes in users resulting in product choice and willingness-to-use. By understanding the impact of USPEs on that process, formulation development can optimize both drug delivery and adherence.

  8. Purification and biochemical characterization of a nattokinase by conversion of shrimp shell with Bacillus subtilis TKU007.

    PubMed

    Wang, San-Lang; Wu, Ying-Ying; Liang, Tzu-Wen

    2011-02-28

    BSN1, a nattokinase, was purified from the culture supernatant of Bacillus subtilis TKU007 with shrimp shell wastes as the sole carbon/nitrogen source. The BSN1 was purified to homogeneity by three-step procedure with a 515-fold increase in specific activity and 12% recovery. The molecular masses of BSN1 determined by SDS-PAGE and gel filtrations were approximately 30 kDa and 28 kDa, respectively. The results of peptide mass mapping showed that four tryptic peptides of BSN1 were identical to the nattokinase from B. subtilis (GenBank accession number gi14422313) with 37% sequence coverage. The N-terminal amino acid sequence of the first 12 amino acids of BSN1 was AQSVPYGISQIK. The optimum pH, optimum temperature, pH stability, and thermal stability of BSN1 were 8, 40 °C, pH 4-11, and less than 50°C, respectively. BSN1 was inhibited completely by PMSF, indicating that the BSN1 was a serine protease. Using this method, B. subtilis TKU007 produces a nattokinase/fibrinolytic enzyme and this enzyme may be considered as a new source for thrombolytic agents. Copyright © 2010 Elsevier B.V. All rights reserved.

  9. Pharmacodynamic Activity of Dapivirine and Maraviroc Single Entity and Combination Topical Gels for HIV-1 Prevention.

    PubMed

    Dezzutti, Charlene S; Yandura, Sarah; Wang, Lin; Moncla, Bernard; Teeple, Elizabeth A; Devlin, Brid; Nuttall, Jeremy; Brown, Elizabeth R; Rohan, Lisa C

    2015-11-01

    Dapivirine (DPV), a non-nucleoside reverse transcriptase inhibitor, and maraviroc (MVC), a CCR5 antagonist, were formulated into aqueous gels designed to prevent mucosal HIV transmission. 0.05% DPV, 0.1% MVC, 0.05% DPV/0.1% MVC and placebo gels were evaluated for pH, viscosity, osmolality, and in vitro release. In vitro assays and mucosal tissues were used to evaluate anti-HIV activity. Viability (Lactobacilli only) and epithelial integrity in cell lines and mucosal tissues defined safety. The gels were acidic and viscous. DPV gel had an osmolality of 893 mOsm/kg while the other gels had an osmolality of <100 mOsm/kg. MVC release was similar from the single and combination gels (~5 μg/cm(2)/min(1/2)), while DPV release was 10-fold less from the single as compared to the combination gel (0.4331 μg/cm(2)/min(1/2)). Titrations of the gels showed 10-fold more drug was needed to protect ectocervical than colonic tissue. The combination gel showed ~10- and 100-fold improved activity as compared to DPV and MVC gel, respectively. All gels were safe. The DPV/MVC gel showed a benefit blocking HIV infection of mucosal tissue compared to the single entity gels. Combination products with drugs affecting unique steps in the viral replication cycle would be advantageous for HIV prevention.

  10. Investigation of some topical formulations containing dexpanthenol.

    PubMed

    Stozkowska, Wiesława; Piekoś, Ryszard

    2004-01-01

    Owing to its ability to regenerate epidermal cells Dexpanthenol (D-panthenol; chemically known as (+)-2,4-dihydroxy-N-(3-hydroxypropyl)-3,3-dimethylbutyramide) has found use for the treatment of patholytic ileus and postoperative distention. The purpose of research was to develop a gel containing dexpanthenol by monitoring the effect of various concentrations of a gelating agent on the activity of the ciliary apparatus. A system containing 2.5% of hydroxyethylcellulose was optimal for the preparation of the gel. Together with a formulation containing 5% of dexpanthenol, drops with equal concentration of the active compound were tested for comparison. Physical characteristics, such as osmotic pressure, acidity, density and viscosity of the preparation were determined as well as its microbiological sterility. The anti-inflammatory activity of the gel was determined following its topical application. Epidermal tests showed its good tolerance after topical application to the shaved skin of guinea pigs.

  11. A novel cosmetic antifungal/anti-inflammatory topical gel for the treatment of mild to moderate seborrheic dermatitis of the face: an open-label trial utilizing clinical evaluation and erythema-directed digital photography.

    PubMed

    Dall' Oglio, Federica; Tedeschi, Aurora; Fusto, Carmelinda M; Lacarrubba, Francesco; Dinotta, Franco; Micali, Giuseppe

    2017-10-01

    Topical cosmetic agents may play a role in the management of facial seborrheic dermatitis by reducing inflammation and scale production. Advanced digital photography, equipped with technology able to provide a detailed evaluation of red skin components corresponding to vascular flare (erythema-directed digital photography), is a useful tool for evaluation of erythema in patients affected by inflammatory dermatoses. The aim of this study was to assess the efficacy and safety of a new cosmetic topical gel containing piroctone olamine, lactoferrin, glycero-phospho-inositol, and Aloe vera for the treatment of facial seborrheic dermatitis by clinical and advanced digital photography evaluation. An open-label, prospective, clinical trial was conducted on 25 patients with mild to moderate facial seborrheic dermatitis. Subjects were instructed to apply the gel twice daily for 45 days. The clinical efficacy was evaluated by measuring at baseline, at day 15 and 45 the degree of desquamation (by clinical examination) and erythema (by digital photography technology via VISIA-CR™ system equipped with RBX™), using a 5-point severity scale, and pruritus (by subject-completed Visual Analogue Scale; scale from 0 to 100 mm). Finally, at baseline and at the end of the study, IGA (Investigator Global Assessment) was performed using a 5-point severity scale (from 0 = worsening to 4 = excellent response). At the end of treatment, a significant reduction (P<0.001) of all considered parameters was observed. Moreover, an excellent response (>80% improvement) was recorded in 47.9% of patients, with no case of worsening. No signs of local intolerance were documented. The tested cosmetic topical gel was effective in treating mild to moderate seborrheic dermatitis of the face. Erythema-directed digital photography may represent a noteworthy tool for the therapeutic monitoring of facial seborrheic dermatitis and an important adjunct aid in the dermatologic clinical practice.

  12. Novel microemulsion-based gel formulation of tazarotene for therapy of acne.

    PubMed

    Patel, Mrunali Rashmin; Patel, Rashmin Bharatbhai; Parikh, Jolly R; Patel, Bharat G

    2016-12-01

    The objective of this study was to develop and evaluate a novel microemulsion based gel formulation containing tazarotene for targeted topical therapy of acne. Psudoternary phase diagrams were constructed to obtain the concentration range of oil, surfactant, and co-surfactant for microemulsion formation. The optimized microemulsion formulation containing 0.05% tazarotene was formulated by spontaneous microemulsification method consisting of 10% Labrafac CC, mixed emulsifiers 15% Labrasol-Cremophor-RH 40 (1:1), 15% Capmul MCM, and 60% distilled water (w/w) as an external phase. All plain and tazarotene-loaded microemulsions were clear and showed physicochemical parameters for desired topical delivery and stability. The permeation profiles of tazarotene through rat skin from optimized microemulsion formulation followed the Higuchi model for controlled permeation. Microemulsion-based gel was prepared by incorporating Carbopol®971P NF in optimized microemulsion formulation having suitable skin permeation rate and skin uptake. Microemulsion-based gel showed desired physicochemical parameters and demonstrated advantage over marketed formulation in improving the skin tolerability of tazarotene indicating its potential in improving its topical delivery. The developed microemulsion-based gel may be a potential drug delivery vehicle for targeted topical delivery of tazarotene in the treatment of acne.

  13. Pharmacodynamic activity of Dapivirine and Maraviroc single entity and combination topical gels for HIV-1 prevention

    PubMed Central

    Dezzutti, Charlene S.; Yandura, Sarah; Wang, Lin; Moncla, Bernard; Teeple, Elizabeth A.; Devlin, Brid; Nuttall, Jeremy; Brown, Elizabeth R.; Rohan, Lisa C.

    2015-01-01

    Purpose Dapivirine (DPV), a non-nucleoside reverse transcriptase inhibitor, and maraviroc (MVC), a CCR5 antagonist, were formulated into aqueous gels designed to prevent mucosal HIV transmission. Methods 0.05% DPV, 0.1% MVC, 0.05% DPV/0.1% MVC and placebo gels were evaluated for pH, viscosity, osmolality, and in vitro release. In vitro assays and mucosal tissues were used to evaluate anti-HIV activity. Viability (Lactobacilli only) and epithelial integrity in cell lines and mucosal tissues defined safety. Results The gels were acidic and viscous. DPV gel had an osmolality of 893 mOsm/kg while the other gels had an osmolality of <100 mOsm/kg. MVC release was similar from the single and combination gels (~5 μg/cm2/min1/2), while DPV release was 10-fold less from the single as compared to the combination gel (0.4331 μg/cm2/min1/2). Titrations of the gels showed 10-fold more drug was needed to protect ectocervical than colonic tissue. The combination gel showed ~10- and 100-fold improved activity as compared to DPV and MVC gel, respectively. All gels were safe. Conclusions The DPV/MVC gel showed a benefit blocking HIV infection of mucosal tissue compared to the single entity gels. Combination products with drugs affecting unique steps in the viral replication cycle would be advantageous for HIV prevention. PMID:26078001

  14. Topical anesthesia in phacoemulsification.

    PubMed

    Waheeb, Saad

    2010-09-01

    To evaluate the efficacy of topical anesthesia; topical Benoxinate 0.4% (Oxybuprocaine) and Xylocaine (Lidocaine) gel, in selected cataract patients as an alternative to peribulbar or retrobulbar block anesthesia during cataract surgery. Prospective non-comparative evaluation of patients' and surgeon's satisfaction at the end of the procedure. Three hundred patients (300 eyes) were included in the study. The procedure was explained to patients with details regarding what will happen and what to expect during surgery. All patients received topical anesthesia with Benoxinate 0.4% eye drops and Xylocaine gel 2%. All surgeries were done by the same surgeon using the same machine (updated LEGACY phacoemulsifier, Alcon) and approach (clear corneal incision) and followed by a foldable intraocular lens (IOL) implantation. None of the patients had severe pain during the procedure; only 2% (six of 300) required use of intravenous sedation (Propofol), both the surgeon's and the patients' satisfaction were high. Eye movements and blepharospasm were not significant problems, and no serious complications occurred. Rate of vitreous loss due to posterior capsule tear/rupture was within literature reported range and not different from our previous experience. Topical anesthesia is a satisfactory and safe alternative to retrobulbar and peribulbar anesthesia for clear corneal phacoemulsification and intraocular lens implantation in selected cataract patients in the hands of experienced cataract surgeon.

  15. Topical anesthesia in phacoemulsification

    PubMed Central

    Waheeb, Saad

    2010-01-01

    Purpose: To evaluate the efficacy of topical anesthesia; topical Benoxinate 0.4% (Oxybuprocaine) and Xylocaine (Lidocaine) gel, in selected cataract patients as an alternative to peribulbar or retrobulbar block anesthesia during cataract surgery. Materials and Methods: Prospective non-comparative evaluation of patients’ and surgeon’s satisfaction at the end of the procedure. Three hundred patients (300 eyes) were included in the study. The procedure was explained to patients with details regarding what will happen and what to expect during surgery. All patients received topical anesthesia with Benoxinate 0.4% eye drops and Xylocaine gel 2%. All surgeries were done by the same surgeon using the same machine (updated LEGACY phacoemulsifier, Alcon) and approach (clear corneal incision) and followed by a foldable intraocular lens (IOL) implantation. Results: None of the patients had severe pain during the procedure; only 2% (six of 300) required use of intravenous sedation (Propofol), both the surgeon’s and the patients’ satisfaction were high. Eye movements and blepharospasm were not significant problems, and no serious complications occurred. Rate of vitreous loss due to posterior capsule tear/rupture was within literature reported range and not different from our previous experience. Conclusion: Topical anesthesia is a satisfactory and safe alternative to retrobulbar and peribulbar anesthesia for clear corneal phacoemulsification and intraocular lens implantation in selected cataract patients in the hands of experienced cataract surgeon. PMID:21120050

  16. 46 CFR 164.007-6 - Test report.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 46 Shipping 6 2011-10-01 2011-10-01 false Test report. 164.007-6 Section 164.007-6 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) EQUIPMENT, CONSTRUCTION, AND MATERIALS: SPECIFICATIONS AND APPROVAL MATERIALS Structural Insulations § 164.007-6 Test report. (a) The test report required shall contain at least the following: (1)...

  17. 46 CFR 164.007-6 - Test report.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 46 Shipping 6 2014-10-01 2014-10-01 false Test report. 164.007-6 Section 164.007-6 Shipping COAST...: SPECIFICATIONS AND APPROVAL MATERIALS Structural Insulations § 164.007-6 Test report. (a) The test report required shall contain at least the following: (1) Name of manufacturer. (2) Purpose of test. (3) Test...

  18. Nanoencapsulation of Rose-Hip Oil Prevents Oil Oxidation and Allows Obtainment of Gel and Film Topical Formulations.

    PubMed

    Contri, Renata V; Kulkamp-Guerreiro, Irene C; da Silva, Sheila Janine; Frank, Luiza A; Pohlmann, Adriana R; Guterres, Silvia S

    2016-08-01

    The rose-hip oil holds skin regenerating properties with applications in the dermatological and cosmetic area. Its nanoencapsulation might favor the oil stability and its incorporation into hydrophilic formulations, besides increasing the contact with the skin and prolonging its effect. The aim of the present investigation was to develop suitable rose-hip-oil-loaded nanocapsules, to verify the nanocapsule effect on the UV-induced oxidation of the oil and to obtain topical formulations by the incorporation of the nanocapsules into chitosan gel and film. The rose-hip oil (500 or 600 μL), polymer (Eudragit RS100®, 100 or 200 mg), and acetone (50 or 100 mL) contents were separately varied aiming to obtain an adequate size distribution. The results led to a combination of the factors acetone and oil. The developed formulation showed average diameter of 158 ± 6 nm with low polydispersity, pH of 5.8 ± 0.9, zeta potential of +9.8 ± 1.5 mV, rose-hip oil content of 54 ± 1 μL/mL and tendency to reversible creaming. No differences were observed in the nanocapsules properties after storage. The nanoencapsulation of rose-hip oil decreased the UVA and UVC oxidation of the oil. The chitosan gel and film containing rose-hip-oil-loaded nanocapsules showed suitable properties for cutaneous use. In conclusion, it was possible to successfully obtain rose-hip-oil-loaded nanocapsules and to confirm the nanocapsules effect in protecting the oil from the UV rays. The chitosan gel and film were considered interesting alternatives for incorporating the nanoencapsulated rose-hip oil, combining the advantages of the nanoparticles to the advantages of chitosan.

  19. Designing Preclinical Perceptibility Measures to Evaluate Topical Vaginal Gel Formulations: Relating User Sensory Perceptions and Experiences to Formulation Properties

    PubMed Central

    Fava, Joseph L.; Rosen, Rochelle K.; Vargas, Sara; Shaw, Julia G.; Kojic, E. Milu; Kiser, Patrick F.; Friend, David R.; Katz, David F.

    2014-01-01

    Abstract The effectiveness of any biomedical prevention technology relies on both biological efficacy and behavioral adherence. Microbicide trials have been hampered by low adherence, limiting the ability to draw meaningful conclusions about product effectiveness. Central to this problem may be an inadequate conceptualization of how product properties themselves impact user experience and adherence. Our goal is to expand the current microbicide development framework to include product “perceptibility,” the objective measurement of user sensory perceptions (i.e., sensations) and experiences of formulation performance during use. For vaginal gels, a set of biophysical properties, including rheological properties and measures of spreading and retention, may critically impact user experiences. Project LINK sought to characterize the user experience in this regard, and to validate measures of user sensory perceptions and experiences (USPEs) using four prototype topical vaginal gel formulations designed for pericoital use. Perceptibility scales captured a range of USPEs during the product application process (five scales), ambulation after product insertion (six scales), and during sexual activity (eight scales). Comparative statistical analyses provided empirical support for hypothesized relationships between gel properties, spreading performance, and the user experience. Project LINK provides preliminary evidence for the utility of evaluating USPEs, introducing a paradigm shift in the field of microbicide formulation design. We propose that these user sensory perceptions and experiences initiate cognitive processes in users resulting in product choice and willingness-to-use. By understanding the impact of USPEs on that process, formulation development can optimize both drug delivery and adherence. PMID:24180360

  20. Halogen-bonding-triggered supramolecular gel formation

    NASA Astrophysics Data System (ADS)

    Meazza, Lorenzo; Foster, Jonathan A.; Fucke, Katharina; Metrangolo, Pierangelo; Resnati, Giuseppe; Steed, Jonathan W.

    2013-01-01

    Supramolecular gels are topical soft materials involving the reversible formation of fibrous aggregates using non-covalent interactions. There is significant interest in controlling the properties of such materials by the formation of multicomponent systems, which exhibit non-additive properties emerging from interaction of the components. The use of hydrogen bonding to assemble supramolecular gels in organic solvents is well established. In contrast, the use of halogen bonding to trigger supramolecular gel formation in a two-component gel (‘co-gel’) is essentially unexplored, and forms the basis for this study. Here, we show that halogen bonding between a pyridyl substituent in a bis(pyridyl urea) and 1,4-diiodotetrafluorobenzene brings about gelation, even in polar media such as aqueous methanol and aqueous dimethylsulfoxide. This demonstrates that halogen bonding is sufficiently strong to interfere with competing gel-inhibitory interactions and create a ‘tipping point’ in gel assembly. Using this concept, we have prepared a halogen bond donor bis(urea) gelator that forms co-gels with halogen bond acceptors.

  1. 48 CFR 1535.007-70 - Contract clauses.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 48 Federal Acquisition Regulations System 6 2014-10-01 2014-10-01 false Contract clauses. 1535.007-70 Section 1535.007-70 Federal Acquisition Regulations System ENVIRONMENTAL PROTECTION AGENCY SPECIAL CATEGORIES OF CONTRACTING RESEARCH AND DEVELOPMENT CONTRACTING 1535.007-70 Contract clauses. The following...

  2. 48 CFR 1535.007-70 - Contract clauses.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 48 Federal Acquisition Regulations System 6 2012-10-01 2012-10-01 false Contract clauses. 1535.007-70 Section 1535.007-70 Federal Acquisition Regulations System ENVIRONMENTAL PROTECTION AGENCY SPECIAL CATEGORIES OF CONTRACTING RESEARCH AND DEVELOPMENT CONTRACTING 1535.007-70 Contract clauses. The following...

  3. 48 CFR 1535.007-70 - Contract clauses.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 48 Federal Acquisition Regulations System 6 2013-10-01 2013-10-01 false Contract clauses. 1535.007-70 Section 1535.007-70 Federal Acquisition Regulations System ENVIRONMENTAL PROTECTION AGENCY SPECIAL CATEGORIES OF CONTRACTING RESEARCH AND DEVELOPMENT CONTRACTING 1535.007-70 Contract clauses. The following...

  4. 48 CFR 1535.007-70 - Contract clauses.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 48 Federal Acquisition Regulations System 6 2011-10-01 2011-10-01 false Contract clauses. 1535.007-70 Section 1535.007-70 Federal Acquisition Regulations System ENVIRONMENTAL PROTECTION AGENCY SPECIAL CATEGORIES OF CONTRACTING RESEARCH AND DEVELOPMENT CONTRACTING 1535.007-70 Contract clauses. The following...

  5. Cumulative irritation potential of topical retinoid formulations.

    PubMed

    Leyden, James J; Grossman, Rachel; Nighland, Marge

    2008-08-01

    Localized irritation can limit treatment success with topical retinoids such as tretinoin and adapalene. The factors that influence irritant reactions have been shown to include individual skin sensitivity, the particular retinoid and concentration used, and the vehicle formulation. To compare the cutaneous tolerability of tretinoin 0.04% microsphere gel (TMG) with that of adapalene 0.3% gel and a standard tretinoin 0.025% cream. The results of 2 randomized, investigator-blinded studies of 2 to 3 weeks' duration, which utilized a split-face method to compare cumulative irritation scores induced by topical retinoids in subjects with healthy skin, were combined. Study 1 compared TMG 0.04% with adapalene 0.3% gel over 2 weeks, while study 2 compared TMG 0.04% with tretinoin 0.025% cream over 3 weeks. In study 1, TMG 0.04% was associated with significantly lower cumulative scores for erythema, dryness, and burning/stinging than adapalene 0.3% gel. However, in study 2, there were no significant differences in cumulative irritation scores between TMG 0.04% and tretinoin 0.025% cream. Measurements of erythema by a chromameter showed no significant differences between the test formulations in either study. Cutaneous tolerance of TMG 0.04% on the face was superior to that of adapalene 0.3% gel and similar to that of a standard tretinoin cream containing a lower concentration of the drug (0.025%).

  6. Short-duration topical treatment of tinea pedis using terbinafine emulsion gel: results of a dose-ranging clinical trial.

    PubMed

    James, Ian G; Loria-Kanza, Yolanda; Jones, Thomas C

    2007-01-01

    In the treatment of tinea pedis, current terbinafine formulations are applied once or twice daily for 7 days. A terbinafine emulsion gel formulation has been developed to provide a 5-day treatment course for tinea pedis. To determine the lowest effective concentration of terbinafine (1% or 3%) emulsion gel applied once daily for 5 days for the treatment of tinea pedis. This double-blind, placebo-controlled study evaluated the efficacy of 1% and 3% terbinafine gel for 5 days in 84 outpatients with tinea pedis. The primary efficacy endpoint was the percentage of patients with effective treatment (negative microscopy and culture with only mild erythema/desquamation/pruritus [total scoregel were significantly higher than with placebo (86% and 68% vs 11%, respectively; p<0.001). Similarly, mycological cure rates were significantly greater with terbinafine 1% and 3% gel (97% and 89%, respectively) than with placebo (22%; p<0.001). Terbinafine 1% emulsion gel used once daily for 5 days was the lowest effective concentration, and was significantly superior to placebo. Both concentrations were effective and safe, providing convenient, short-duration treatment of tinea pedis.

  7. Efficacy and safety of clindamycin-tretinoin gel versus clindamycin or tretinoin alone in acne vulgaris: a randomized, double-blind, vehicle-controlled study.

    PubMed

    Jarratt, Michael T; Brundage, Tom

    2012-03-01

    Topical combination therapy containing a retinoid and an antimicrobial is an effective treatment for acne vulgaris. To evaluate the efficacy and safety of a new topical formulation containing clindamycin phosphate 1.2% and tretinoin 0.025% solubilized in an aqueous-based gel (CT gel). 1,649 participants were randomized 2:2:2:1 to 12 weeks of double-blind treatment with CT gel, clindamycin, tretinoin, or vehicle gel administered once daily. Significantly more participants achieved 2-grade or greater improvement on the Investigator's Static Global Assessment score with CT gel versus clindamycin, tretinoin, or vehicle gel. CT gel produced a significantly greater reduction in absolute number of total lesions versus all other treatment groups, in total and noninflammatory lesions versus clindamycin, and in total and inflammatory lesions versus tretinoin. Local tolerability was similar to that of tretinoin alone; signs and symptoms of irritation were most notable at week 2. There were no more adverse events with CT gel than with tretinoin gel. CT gel is more effective than clindamycin or tretinoin monotherapy, with a safety and tolerability profile similar to that of tretinoin.

  8. Deoxycholate-hydrogels: novel drug carrier systems for topical use.

    PubMed

    Valenta, C; Nowack, E; Bernkop-Schnürch, A

    1999-08-05

    Na-deoxycholate (Na-DOC) forms a viscous thixotropic gel when in contact with excess buffer systems. The resulting gels have been tested as novel drug carrier systems for topical use. The influence of differing amounts of mannitol, glycerol and xylitol on the viscous modulus (G"/Pa) was evaluated by oscillatory measurements. Na-DOC (0.5%) in phosphate buffered saline (PBS) with 5% mannitol was chosen as an optimised formulation, taking into account viscosity, distribution and appearance. The release rate of the model drug rutin through an artificial membrane was higher than those from hydroxyethylcellulose- (HEC) and sodium polyacrylate (NaC934)-gels; permeation through excised rat skin was also highest for the Na-DOC systems. The results indicate that Na-DOC significantly increases the membrane permeability. The microbial stability was in the same range as HEC- and NaC934-gels, making a preservation necessary. Na-DOC-gels are novel low molecular weight, multifunctional drug carriers, which also act as penetration enhancers. Their thixotropy is an additional advantage for better application to large skin areas, nasal, vaginal and buccal membranes. Therefore, Na-DOC-gels can be considered promising, alternative drug carrier systems for topical pharmaceutical as well as cosmetic use.

  9. 46 CFR 164.007-5 - Test requirements.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 46 Shipping 6 2014-10-01 2014-10-01 false Test requirements. 164.007-5 Section 164.007-5 Shipping...: SPECIFICATIONS AND APPROVAL MATERIALS Structural Insulations § 164.007-5 Test requirements. The insulation value of the specimens for the full scale test shall be such that the average temperature of the...

  10. Comparison effect of azithromycin gel 2% with clindamycin gel 1% in patients with acne.

    PubMed

    Mokhtari, Fatemeh; Faghihi, Gita; Basiri, Akram; Farhadi, Sadaf; Nilforoushzadeh, Mohammadali; Behfar, Shadi

    2016-01-01

    Acne vulgaris is the most common skin disease. Local and systemic antimicrobial drugs are used for its treatment. But increasing resistance of Propionibacterium acnes to antibiotics has been reported. In a double-blind clinical trial, 40 patients with mild to moderate acne vulgaris were recruited. one side of the face was treated with Clindamycin Gel 1% and the other side with Azithromycin Topical Gel 2% BID for 8 weeks and then they were assessed. Average age was 21. 8 ± 7 years. 82.5% of them were female. Average number of papules, pustules and comedones was similarly reduced in both groups and, no significant difference was observed between the two groups (P > 0.05, repeated measurs ANOVA). The mean indexes of ASI and TLC also significantly decreased during treatment in both groups, no significant difference was observed between the two groups. (P > 0.05, repeated measurs ANOVA). Also, impact of both drugs on papules and pustules was 2-3 times greater than the effect on comedones. Average satisfaction score was not significant between the two groups (P = 0.6, repeated measurs ANOVA). finally, frequency distribution of complications was not significant between the two groups (P > 0.05, Fisher Exact test). Azithromycin gel has medical impact at least similar to Clindamycin Gel in treatment of mild to moderate acne vulgaris, and it may be consider as suitable drug for resistant acne to conventional topical therapy.

  11. 40 CFR 86.007-23 - Required data.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 40 Protection of Environment 19 2012-07-01 2012-07-01 false Required data. 86.007-23 Section 86...-Fueled and Methanol-Fueled Heavy-Duty Vehicles § 86.007-23 Required data. Section 86.007-23 includes text... § 86.001-23. (b)(3) and (b)(4) [Reserved]. For guidance see § 86.098-23. (c) Emission data—(1...

  12. 40 CFR 86.007-23 - Required data.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 40 Protection of Environment 19 2014-07-01 2014-07-01 false Required data. 86.007-23 Section 86...-Fueled and Methanol-Fueled Heavy-Duty Vehicles § 86.007-23 Required data. Section 86.007-23 includes text...) and (b)(4) [Reserved]. For guidance see § 86.098-23. (c) Emission data from certification vehicles and...

  13. 40 CFR 86.007-23 - Required data.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 40 Protection of Environment 18 2011-07-01 2011-07-01 false Required data. 86.007-23 Section 86...-Fueled and Methanol-Fueled Heavy-Duty Vehicles § 86.007-23 Required data. Section 86.007-23 includes text... § 86.001-23. (b)(3) and (b)(4) [Reserved]. For guidance see § 86.098-23. (c) Emission data—(1...

  14. 40 CFR 86.007-23 - Required data.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 18 2010-07-01 2010-07-01 false Required data. 86.007-23 Section 86...-Fueled and Methanol-Fueled Heavy-Duty Vehicles § 86.007-23 Required data. Section 86.007-23 includes text... § 86.001-23. (b)(3) and (b)(4) [Reserved]. For guidance see § 86.098-23. (c) Emission data—(1...

  15. Formulation and evaluation of a topical niosomal gel containing a combination of benzoyl peroxide and tretinoin for antiacne activity.

    PubMed

    Gupta, Ankush; Singh, Sima; Kotla, Niranjan G; Webster, Thomas J

    2015-01-01

    A skin disease, like acne, is very common and normally happens to everyone at least once in their lifetime. The structure of the stratum corneum is often compared with a brick wall, with corneocytes surrounded by the mortar of the intercellular lipid lamellae. One of the best options for successful drug delivery to the affected area of skin is the use of elastic vesicles (niosomes) which can be transported through the skin through channel-like structures. In this study, a combination of tretinoin (keratolytic agent) and benzoyl peroxide (BPO) (a potent antibacterial) was given by using niosomes as promising carriers for the effective treatment of acne by acting on a pathogenic site. In this section, niosomal gel formulation encapsulated drugs have been evaluated for in vitro, ex vivo, and in vivo, for their predetermined characteristics; and finally the stability of the niosome gel was tested at different temperature conditions for understanding of the storage conditions required for maintaining the quality of formulation attributes. The prepared niosome was found to be in the range of 531 nm with a zeta potential of -43 mV; the entrapment efficiencies of tretinoin (TRA) and BPO niosomes were found to be 96.25%±0.56% and 98.75%±1.25%, respectively. The permeated amount of TRA and BPO from the niosomal gel after 24 hours was calculated as 6.25±0.14 μg/cm(2) and 5.04±0.014 μg/cm(2), respectively. A comparative drug retention study in Wistar rat skin using cream, an alcoholic solution, and a niosomal gel showed 11.54 μg, 2.68 μg, and 15.54 μg amounts of TRA and 68.85 μg, 59.98 μg, and 143.78 μg amounts of BPO were retained in the layers of skin, respectively. In vivo studies of the niosomal gel and antiacne cream of TRA and BPO showed that the niosomal gel was more efficacious than the antiacne cream because niosomal gels with a 4.16-fold lower dose of BPO provided the same therapeutic index at targeted sites in comparison to the antiacne cream.

  16. Formulation and evaluation of a topical niosomal gel containing a combination of benzoyl peroxide and tretinoin for antiacne activity

    PubMed Central

    Gupta, Ankush; Singh, Sima; Kotla, Niranjan G; Webster, Thomas J

    2015-01-01

    A skin disease, like acne, is very common and normally happens to everyone at least once in their lifetime. The structure of the stratum corneum is often compared with a brick wall, with corneocytes surrounded by the mortar of the intercellular lipid lamellae. One of the best options for successful drug delivery to the affected area of skin is the use of elastic vesicles (niosomes) which can be transported through the skin through channel-like structures. In this study, a combination of tretinoin (keratolytic agent) and benzoyl peroxide (BPO) (a potent antibacterial) was given by using niosomes as promising carriers for the effective treatment of acne by acting on a pathogenic site. In this section, niosomal gel formulation encapsulated drugs have been evaluated for in vitro, ex vivo, and in vivo, for their predetermined characteristics; and finally the stability of the niosome gel was tested at different temperature conditions for understanding of the storage conditions required for maintaining the quality of formulation attributes. The prepared niosome was found to be in the range of 531 nm with a zeta potential of −43 mV; the entrapment efficiencies of tretinoin (TRA) and BPO niosomes were found to be 96.25%±0.56% and 98.75%±1.25%, respectively. The permeated amount of TRA and BPO from the niosomal gel after 24 hours was calculated as 6.25±0.14 μg/cm2 and 5.04±0.014 μg/cm2, respectively. A comparative drug retention study in Wistar rat skin using cream, an alcoholic solution, and a niosomal gel showed 11.54 μg, 2.68 μg, and 15.54 μg amounts of TRA and 68.85 μg, 59.98 μg, and 143.78 μg amounts of BPO were retained in the layers of skin, respectively. In vivo studies of the niosomal gel and antiacne cream of TRA and BPO showed that the niosomal gel was more efficacious than the antiacne cream because niosomal gels with a 4.16-fold lower dose of BPO provided the same therapeutic index at targeted sites in comparison to the antiacne cream. PMID

  17. Topical Delivery of Erythromycin Through Cubosomes for Acne.

    PubMed

    Khan, Sana; Jain, Poorva; Jain, Sourabh; Jain, Richa; Bhargava, Saurabh; Jain, Aakanchha

    2018-01-01

    Topical delivery is an attractive route for local and systemic treatment. The novel topical application has many advantages like averting the GI-irritation, preventing the metabolism of drugs in the liver and increasing the bioavailability of the drug over the conventional dosage forms. The aim of present work was to prepare and characterized erythromycin encapsulated cubosomes using different concentrations of glyceryl monooleate and poloxamer 407 by the emulsification method. The prepared dispersion of cubosomes was characterized for surface morphology, particle size, entrapment efficiency and in vitro release. Further, optimized formulation was converted to cubosomal gel by incorporating carbopol 934 at different concentrations. The prepared gel was characterized for homogeneity, pH, viscosity, spreadibility, drug content and in vitro drug release study. The result of optimized cubosomes showed average particle size of 264.5±2.84nm and entrapment efficiency about 95.29±1.32 % and the pH of optimized cubosomal was found to be 6.5, viscosity 2475-8901(cp), drug content 95.29% and the spreadability was found to be 11.74 gm.cm/sec. The in vitro drug release kinetics of optimized formulation was found to follow Korsmeyer peppas model having highest R2 value 0.835 and in vitro drug release of optimized erythromycin loaded cubosomal gel and plain drug gel in 24 hr was found to be 89.91±0.73 and 88.64±2.16, while in 36 hr plain drug gel and cubosomal gel showed drug release about 87.64±0.97 and 91.55±1.09, and sustained release was obtained after 24 hr in case of cubosomal gel. Thus, as a whole it can be concluded that erythromycin loaded cubosomes are effective in topically delivering drug in sustained and non-invasive manner for treatment and prevention of acne. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

  18. Thermoreversible gel formulation containing sodium lauryl sulfate as a potential contraceptive device.

    PubMed

    Haineault, Caroline; Gourde, Pierrette; Perron, Sylvie; Désormeaux, André; Piret, Jocelyne; Omar, Rabeea F; Tremblay, Roland R; Bergeron, Michel G

    2003-08-01

    The contraceptive properties of a gel formulation containing sodium lauryl sulfate were investigated in both in vitro and in vivo models. Results showed that sodium lauryl sulfate inhibited, in a concentration-dependent manner, the activity of sheep testicular hyaluronidase. Sodium lauryl sulfate also completely inhibited human sperm motility as evaluated by the 30-sec Sander-Cramer test. The acid-buffering capacity of gel formulations containing sodium lauryl sulfate increased with the molarity of the citrate buffers used for their preparations. Furthermore, experiments in which semen was mixed with undiluted gel formulations in different proportions confirmed their physiologically relevant buffering capacity. Intravaginal application of the gel formulation containing sodium lauryl sulfate to rabbits before their artificial insemination with freshly ejaculated semen completely prevented egg fertilization. The gel formulation containing sodium lauryl sulfate was fully compatible with nonlubricated latex condoms. Taken together, these results suggest that the gel formulation containing sodium lauryl sulfate could represent a potential candidate for use as a topical vaginal spermicidal formulation to provide fertility control in women.

  19. Comparison of topical anesthetics (EMLA/Oraqix vs. benzocaine) on pain experienced during palatal needle injection.

    PubMed

    Al-Melh, Manal Abu; Andersson, Lars

    2007-05-01

    The aim of this study was to compare the topical anesthetic effect of 20% benzocaine gel with 2.5% lidocaine/2.5% prilocaine (L/P) cream and gel on the pain experienced during palatal anesthetic infiltration. Two groups were studied, each containing 20 subjects. Two types of L/P mixtures were tested, an anesthetic cream (EMLA) and a thermosetting gel (Oraqix), and benzocaine was used as control. The topical agents were applied on the palatal mucosa at the canine region. A needle prick was given on each side every 2 minutes during a period of 10 minutes. The subjects recorded their findings using verbal and VAS scales. Pain scores were significantly less (P < .05) with EMLA and Oraqix than with benzocaine. Topical application of EMLA and Oraqix before palatal anesthetic infiltration is associated with less pain than with benzocaine gel.

  20. Current status of topical antiretroviral chemoprophylaxis.

    PubMed

    Van Damme, Lut; Szpir, Michael

    2012-11-01

    Recent studies suggest that the vaginal delivery of antiretroviral (ARV) agents - such as tenofovir, dapivirine and UC781 - may be a promising way to reduce the high rates of HIV infection among women in developing countries. This review examines these developments. The Microbicide Trials Network 003 study, a large phase IIb trial, was unable to show that daily dosing with 1% tenofovir vaginal gel was effective for HIV prevention. Nevertheless, preclinical and early-phase clinical trials suggest that ARV drugs - formulated in vaginal gels, rings, films, tablets and diaphragms - could be effective for HIV chemoprophylaxis. Investigations of topical chemoprophylaxis methods have seen mixed results in the past 12-18 months. Product adherence may prove to be one of the field's greatest challenges. Phase II and III trials continue to explore different dosing strategies for topical products that contain one or more ARV agents.

  1. Topical microbicides--what's new?

    PubMed

    Karim, Quarraisha Abdool; Baxter, Cheryl; Karim, Salim Abdool

    2013-07-01

    Topical microbicides are an important, promising but complex HIV prevention technology under development. After 11 disappointing effectiveness trial outcomes of 6 candidate products (some tested as multiple doses and formulations) over the past 20 years, there is renewed optimism that a safe and effective microbicide will soon be available if the recent success of coitally linked use of the antiretroviral-based microbicide, 1% tenofovir gel, is confirmed. Studies of new antiviral agents, novel delivery mechanisms, and combination/multipurpose products that address challenges of adherence, enhance the effectiveness of tenofovir gel, and address sexual and reproductive health needs of men and women, including preventing HIV infection, are already underway.

  2. 46 CFR 164.007-7 - Analysis of results.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 46 Shipping 6 2013-10-01 2013-10-01 false Analysis of results. 164.007-7 Section 164.007-7...: SPECIFICATIONS AND APPROVAL MATERIALS Structural Insulations § 164.007-7 Analysis of results. (a) When only one sample is tested, the results of the test shall be binding and no analysis by the Coast Guard will be...

  3. 46 CFR 164.007-7 - Analysis of results.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 46 Shipping 6 2010-10-01 2010-10-01 false Analysis of results. 164.007-7 Section 164.007-7...: SPECIFICATIONS AND APPROVAL MATERIALS Structural Insulations § 164.007-7 Analysis of results. (a) When only one sample is tested, the results of the test shall be binding and no analysis by the Coast Guard will be...

  4. 46 CFR 164.007-7 - Analysis of results.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 46 Shipping 6 2011-10-01 2011-10-01 false Analysis of results. 164.007-7 Section 164.007-7...: SPECIFICATIONS AND APPROVAL MATERIALS Structural Insulations § 164.007-7 Analysis of results. (a) When only one sample is tested, the results of the test shall be binding and no analysis by the Coast Guard will be...

  5. 46 CFR 164.007-7 - Analysis of results.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 46 Shipping 6 2012-10-01 2012-10-01 false Analysis of results. 164.007-7 Section 164.007-7...: SPECIFICATIONS AND APPROVAL MATERIALS Structural Insulations § 164.007-7 Analysis of results. (a) When only one sample is tested, the results of the test shall be binding and no analysis by the Coast Guard will be...

  6. 46 CFR 164.007-7 - Analysis of results.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 46 Shipping 6 2014-10-01 2014-10-01 false Analysis of results. 164.007-7 Section 164.007-7...: SPECIFICATIONS AND APPROVAL MATERIALS Structural Insulations § 164.007-7 Analysis of results. (a) When only one sample is tested, the results of the test shall be binding and no analysis by the Coast Guard will be...

  7. Topical Microbicides and HIV Prevention in the Female Genital Tract

    PubMed Central

    Cottrell, Mackenzie L; Kashuba, Angela D. M.

    2014-01-01

    Worldwide, HIV disproportionately affects women who are often unable to negotiate traditional HIV preventive strategies such as condoms. In the absence of an effective vaccine or cure, chemoprophylaxis may be a valuable self-initiated alternative. Topical microbicides have been investigated as one such option. The first generation topical microbicides were non-specific, broad-spectrum antimicrobial agents, including surfactants, polyanions, and acid buffering gels, that generally exhibited contraceptive properties. After extensive clinical study, none prevented HIV infection, and their development was abandoned. Second generation topical microbicides include agents with selective mechanisms of antiviral activity. Most are currently being used for, or have previously been explored as, drugs for treatment of HIV. The most advanced of these is tenofovir 1% gel: the first topical agent shown to significantly reduce HIV infection by 39% compared to placebo. This review summarizes the evolution of topical microbicides for HIV chemoprophylaxis, highlights important concepts learned, and offers current and future considerations for this area of research. PMID:24664786

  8. Formulation, pharmacokinetics and pharmacodynamics of topical microbicides

    PubMed Central

    Adams, Jessica L.; Kashuba, Angela D.M.

    2013-01-01

    The development of safe topical microbicides that effectively prevent human immunodeficiency virus (HIV) infection is a major goal in curbing the human immunodeficiency virus pandemic. A number of past failures resulting from mucosal toxicity or lack of efficacy have informed the field. Products that caused toxicity to the female genital tract mucosa, and thereby increased the likelihood of HIV acquisition, included nonoxynol 9, cellulose sulfate, and C31 G vaginal gel Savvy®. Topical products that were ineffective in preventing HIV infection include BufferGel®, Carraguard®, and PRO 2000®. Antiretroviral drugs such as tenofovir and dapivirine formulated into microbicide products have shown promise, but there is much to learn about ideal product formulation and acceptability, and drug distribution and disposition (pharmacokinetics). Current formulations for water-soluble molecules include vaginally or rectally applied gels, vaginal rings, films and tablets. Dosing strategies (e.g. coitally dependent or independent) will be based on the pharmacokinetics of the active ingredient and the tolerance for less than perfect adherence. PMID:22306523

  9. Topical lignocaine for vaginismus: a case report.

    PubMed

    Praharaj, S K; Verma, P; Arora, M

    2006-01-01

    Vaginismus is a sexual dysfunction in which spasm of vaginal musculature precludes penetrative intercourse. In many cases associated pain or fear of pain may contribute to the maintenance of vaginismus. We report a case of primary vaginismus with associated pain that benefited from topical application of lignocaine gel along with systematic desensitization resulting in successful consummation, and suggest that it may be a useful adjunct during finger dilatation in the treatment of vaginismus, specifically in patients who have associated pain or areas of hyperesthesia in the introitus.

  10. 40 CFR 600.007-80 - Vehicle acceptability.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 29 2010-07-01 2010-07-01 false Vehicle acceptability. 600.007-80... FUEL ECONOMY AND CARBON-RELATED EXHAUST EMISSIONS OF MOTOR VEHICLES Fuel Economy Regulations for 1977 and Later Model Year Automobiles-General Provisions § 600.007-80 Vehicle acceptability. (a) All...

  11. Skin regeneration in deep second-degree scald injuries either by infusion pumping or topical application of recombinant human erythropoietin gel.

    PubMed

    Giri, Priya; Ebert, Sabine; Braumann, Ulf-Dietrich; Kremer, Mathias; Giri, Shibashish; Machens, Hans-Günther; Bader, Augustinus

    2015-01-01

    Large doses of recombinant growth factors formulated in solution form directly injected into the body is usual clinical practice in treating second-degree scald injuries, with promising results, but this approach creates side effects; furthermore, it may not allow appropriate levels of the factor to be sensed by the target injured tissue/organ in the specific time frame, owing to complications arising from regeneration. In this research, two delivery methods (infusion pumping and local topical application) were applied to deliver recombinant human erythropoietin (rHuEPO) for skin regeneration. First, rHuEPO was given in deep second-degree scald injury sites in mice by infusion pump. Vascularization was remarkably higher in the rHuEPO pumping group than in controls. Second, local topical application of rHuEPO gel was given in deep second-degree scald injury sites in rats. Histological analysis showed that epithelialization rate was significantly higher in the rHuEPO gel-treated group than in controls. Immunohistochemical studies showed that the rHuEPO gel-treated group showed remarkably higher expression of skin regeneration makers than the control group. An accurate method for visualization and quantification of blood vessel networks in target areas has still not been developed up to this point, because of technical difficulties in detecting such thin blood vessels. A method which utilizes a series of steps to enhance the image, removes noise from image background, and tracks the vessels edges for vessel segmentation and quantification has been used in this study. Using image analysis methods, we were able to detect the microvascular networks of newly formed blood vessels (less than 500 μm thickness), which participate in the healing process, providing not only nutrition and oxygen to grow tissues but also necessary growth factors to grow tissue cells for complete skin regeneration. The rHuEPO-treated group showed higher expression of stem cell markers (CD 31, CD

  12. Skin regeneration in deep second-degree scald injuries either by infusion pumping or topical application of recombinant human erythropoietin gel

    PubMed Central

    Giri, Priya; Ebert, Sabine; Braumann, Ulf-Dietrich; Kremer, Mathias; Giri, Shibashish; Machens, Hans-Günther; Bader, Augustinus

    2015-01-01

    Large doses of recombinant growth factors formulated in solution form directly injected into the body is usual clinical practice in treating second-degree scald injuries, with promising results, but this approach creates side effects; furthermore, it may not allow appropriate levels of the factor to be sensed by the target injured tissue/organ in the specific time frame, owing to complications arising from regeneration. In this research, two delivery methods (infusion pumping and local topical application) were applied to deliver recombinant human erythropoietin (rHuEPO) for skin regeneration. First, rHuEPO was given in deep second-degree scald injury sites in mice by infusion pump. Vascularization was remarkably higher in the rHuEPO pumping group than in controls. Second, local topical application of rHuEPO gel was given in deep second-degree scald injury sites in rats. Histological analysis showed that epithelialization rate was significantly higher in the rHuEPO gel-treated group than in controls. Immunohistochemical studies showed that the rHuEPO gel-treated group showed remarkably higher expression of skin regeneration makers than the control group. An accurate method for visualization and quantification of blood vessel networks in target areas has still not been developed up to this point, because of technical difficulties in detecting such thin blood vessels. A method which utilizes a series of steps to enhance the image, removes noise from image background, and tracks the vessels edges for vessel segmentation and quantification has been used in this study. Using image analysis methods, we were able to detect the microvascular networks of newly formed blood vessels (less than 500 μm thickness), which participate in the healing process, providing not only nutrition and oxygen to grow tissues but also necessary growth factors to grow tissue cells for complete skin regeneration. The rHuEPO-treated group showed higher expression of stem cell markers (CD 31, CD

  13. Azelaic acid 15% gel in the treatment of rosacea.

    PubMed

    Gollnick, Harald; Layton, Alison

    2008-10-01

    Rosacea represents a chronic inflammatory dermatosis of uncertain pathophysiology. There are several associated risk factors and the need for long-term treatment is well recognized. This diverse disease is frequently difficult to manage and has a significant impact on quality of life. There are several topical and oral treatments available, of which azelaic acid 15% gel (Finacea) is the first new treatment for rosacea in more than a decade. Azelaic acid per se has multiple modes of action in rosacea, but an anti-inflammatory effect achieved by reducing reactive oxygen species appears to be the main pharmacological action. Clinical studies have shown that azelaic acid 15% gel is an effective and safe first-line topical therapeutic option in patients with mild-to-moderate papulopustular rosacea. Significant continuous improvement in the number of inflammatory lesions and in erythema has been shown over a period of 15 weeks. Adverse effects associated with azelaic acid 15% gel are mostly mild or transient and do not usually necessitate discontinuation of therapy.

  14. Measuring Dilution of Microbicide Gels with Optical Imaging

    PubMed Central

    Drake, Tyler K.; Shah, Tejen; Peters, Jennifer J.; Wax, Adam; Katz, David F.

    2013-01-01

    We present a novel approach for measuring topical microbicide gel dilution using optical imaging. The approach compares gel thickness measurements from fluorimetry and multiplexed low coherence interferometry in order to calculate dilution of a gel. As a microbicide gel becomes diluted at fixed thickness, its mLCI thickness measurement remains constant, while the fluorimetry signal decreases in intensity. The difference between the two measurements is related to the extent of gel dilution. These two optical modalities are implemented in a single endoscopic instrument that enables simultaneous data collection. A preliminary validation study was performed with in vitro placebo gel measurements taken in a controlled test socket. It was found that change in slope of the regression line between fluorimetry and mLCI based measurements indicates dilution. A dilution calibration curve was then generated by repeating the test socket measurements with serial dilutions of placebo gel with vaginal fluid simulant. This methodology can provide valuable dilution information on candidate microbicide products, which could substantially enhance our understanding of their in vivo functioning. PMID:24340006

  15. The efficacy of a topical anesthetic gel in the relief of pain associated with localized alveolar osteitis.

    PubMed

    Burgoyne, Corey C; Giglio, James A; Reese, Sarah E; Sima, Adam P; Laskin, Daniel M

    2010-01-01

    This prospective randomized clinical study assessed the efficacy of pain control for postextraction alveolar osteitis comparing the use of eugenol on a gauze strip versus a thermosetting gel containing 2.5% prilocaine and 2.5% lidocaine. Thirty-five patients who presented with postextraction alveolar osteitis were randomly assigned to either a control group or test group. After irrigation of the extraction site with normal saline solution, the control patients were treated with eugenol on a gauze strip placed in the socket and the test patients were treated with the thermosetting gel placed directly into the socket. All patients were given a series of visual analog scales to record their pretreatment pain and post-treatment pain at 5, 10, and 15 minutes and then at 1-hour increments during waking hours for the next 48 hours. They were also given a prescription for an analgesic to use for breakthrough pain during the 48-hour period, if necessary, and instructed to record the dose and timing of any pain medication taken. All patients were seen for follow-up at 48 hours after treatment. The mean pretreatment pain score was 6.72 on a scale ranging from 1 to 10 for the eugenol group and 6.37 for the prilocaine-lidocaine group (SE, 0.46), and the 2 groups were not different (P = .62). In the immediate post-treatment period (0-15 minutes) the pain levels were significantly reduced in both groups (Ps < .001). However, the thermosetting gel produced a significantly greater reduction in pain (mean, 3.23; SE, 0.62) than the eugenol (mean, 4.83; SE, 0.43) (P = .022). Over the next 48 hours, the pain level was nominally less with the thermosetting gel, but this difference was not statistically significant (Ps = .2). Although the efficacy of the 2 treatments was not significantly different, the nominal superiority and ease of using the thermosetting gel warrant further investigation.

  16. Recent advances in topical anesthesia

    PubMed Central

    2016-01-01

    Topical anesthetics act on the peripheral nerves and reduce the sensation of pain at the site of application. In dentistry, they are used to control local pain caused by needling, placement of orthodontic bands, the vomiting reflex, oral mucositis, and rubber-dam clamp placement. Traditional topical anesthetics contain lidocaine or benzocaine as active ingredients and are used in the form of solutions, creams, gels, and sprays. Eutectic mixtures of local anesthesia cream, a mixture of various topical anesthetics, has been reported to be more potent than other anesthetics. Recently, new products with modified ingredients and application methods have been introduced into the market. These products may be used for mild pain during periodontal treatment, such as scaling. Dentists should be aware that topical anesthetics, although rare, might induce allergic reactions or side effects as a result of an overdose. Topical anesthetics are useful aids during dental treatment, as they reduce dental phobia, especially in children, by mitigating discomfort and pain. PMID:28879311

  17. Nanoparticle-Based Topical Ophthalmic Gel Formulation for Sustained Release of Hydrocortisone Butyrate.

    PubMed

    Yang, Xiaoyan; Trinh, Hoang M; Agrahari, Vibhuti; Sheng, Ye; Pal, Dhananjay; Mitra, Ashim K

    2016-04-01

    This study was conducted to develop formulations of hydrocortisone butyrate (HB)-loaded poly(D,L-lactic-co-glycolic acid) nanoparticles (PLGA NP) suspended in thermosensitive gel to improve ocular bioavailability of HB for the treatment of bacterial corneal keratitis. PLGA NP with different surfactants such as polyvinyl alcohol (PVA), pluronic F-108, and chitosan were prepared using oil-in-water (O/W) emulsion evaporation technique. NP were characterized with respect to particle size, entrapment efficiency, polydispersity, drug loading, surface morphology, zeta potential, and crystallinity. In vitro release of HB from NP showed a biphasic release pattern with an initial burst phase followed by a sustained phase. Such burst effect was completely eliminated when nanoparticles were suspended in thermosensitive gels and zero-order release kinetics was observed. In HCEC cell line, chitosan-emulsified NP showed the highest cellular uptake efficiency over PVA- and pluronic-emulsified NP (59.09 ± 6.21%, 55.74 ± 6.26%, and 62.54 ± 3.30%, respectively) after 4 h. However, chitosan-emulsified NP indicated significant cytotoxicity of 200 and 500 μg/mL after 48 h, while PVA- and pluronic-emulsified NP exhibited no significant cytotoxicity. PLGA NP dispersed in thermosensitive gels can be considered as a promising drug delivery system for the treatment of anterior eye diseases.

  18. Effects of topical arnica gel on post-laser treatment bruises.

    PubMed

    Alonso, Delilah; Lazarus, Melissa C; Baumann, Leslie

    2002-08-01

    Claims have been made suggesting that topical arnica prevents and speeds the resolution of bruises, yet there are no well-designed placebo-controlled studies to date evaluating topical arnica's effect on bruising. To compare the efficacy of topical arnica in the prevention and resolution of laser-induced bruising. Nineteen patients with facial telangiectases were enrolled in this randomized, double-blinded, placebo-controlled study and were divided into pretreatment and posttreatment groups. The pretreatment group applied arnica with vehicle to one side of the face and vehicle alone to the other side of the face twice a day for 2 weeks prior to laser treatment. The posttreatment group followed the same procedure for 2 weeks after laser treatment. On day 0, all patients were treated for facial telangiectases using a 585 nm pulsed dye laser. Bruising was assessed using a visual analog scale on days 0, 3, 7, 10, 14, and 17 by the patient and the physician. In addition, photographs taken at each of the follow-up visits were later assessed by a second physician using the visual analog scale. There was no statistically significant difference between the mean scores of arnica and vehicle (P = 0.496) and the mean scores of arnica and vehicle (P = 0.359) in the pretreatment and posttreatment groups, respectively. No significant difference was found between topical arnica and vehicle in the prevention or resolution of bruising.

  19. 46 CFR 164.007-6 - Test report.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 46 Shipping 6 2010-10-01 2010-10-01 false Test report. 164.007-6 Section 164.007-6 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) EQUIPMENT, CONSTRUCTION, AND MATERIALS..., smoke or gas emission, glow, flame emission, and any other important data. The time of each observation...

  20. A meta-analysis of platelet gel for prevention of sternal wound infections following cardiac surgery

    PubMed Central

    Kirmani, Bilal H.; Jones, Siôn G.; Datta, Subir; McLaughlin, Edward K.; Hoschtitzky, Andreas J.

    2017-01-01

    Deep sternal wound infection and bleeding are devastating complications following cardiac surgery, which may be reduced by topical application of autologous platelet gel. Systematic review identified seven comparative studies involving 4,692 patients. Meta-analysis showed significant reductions in all sternal wound infections (odds ratio 3.48 [1.08–11.23], p=0.04) and mediastinitis (odds ratio 2.69 [1.20–6.06], p=0.02) but not bleeding. No adverse events relating to the use of topical platelet-rich plasma were reported. The use of autologous platelet gel in cardiac surgery appears to provide significant reductions in serious sternal wound infections, and its use is unlikely to be associated with significant risk. PMID:27177403

  1. Effect of topical application of dipyrone on dental sensitivity reduction after in-office dental bleaching: A randomized, triple-blind multicenter clinical trial.

    PubMed

    Rezende, Márcia; Chemin, Kaprice; Vaez, Savil Costa; Peixoto, Aline Carvalho; Rabelo, Jéssica de Freitas; Braga, Stella Sueli Lourenço; Faria-E-Silva, André Luis; Silva, Gisele Rodrigues da; Soares, Carlos José; Loguercio, Alessandro D; Reis, Alessandra

    2018-05-01

    Tooth sensitivity commonly occurs during and immediately after dental bleaching. The authors conducted a trial to compare tooth sensitivity after in-office bleaching after the use of either a topical dipyrone or placebo gel. A split-mouth, triple-blind, randomized, multicenter clinical trial was conducted among 120 healthy adults having teeth that were shade A2 or darker. The facial tooth surfaces of the right or left sides of the maxillary arch of each patient were randomly assigned to receive either topical dipyrone or placebo gel before 2 in-office bleaching sessions (35% hydrogen peroxide) separated by 2 weeks. Visual analog and numerical rating scales were used to record tooth sensitivity during and up to 48 hours after bleaching. Tooth color change from baseline to 1 month after bleaching was measured with shade guide and spectrophotometer measures. The primary outcome variable was absolute risk of tooth sensitivity. An intention-to-treat analysis was used to analyze data from all patients who were randomly assigned to receive the dipyrone and placebo gels. No statically significant difference was found in the absolute risk of tooth sensitivity between the dipyrone and placebo gels (83% and 90%, respectively, P = .09; relative risk, 0.92; 95% confidence interval, 0.8 to 1.0). A whitening effect was observed in both groups with no statistically significant difference (P > .05) between them. No adverse effects were observed. Topical use of dipyrone gel before tooth bleaching, at the levels used in this study, did not reduce the risk or intensity of bleaching-induced tooth sensitivity. Topical application of dipyrone gel does not reduce bleaching-induced tooth sensitivity. Copyright © 2018 American Dental Association. Published by Elsevier Inc. All rights reserved.

  2. Nonaqueous gel for the transdermal delivery of a DTPA penta-ethyl ester prodrug.

    PubMed

    Zhang, Yong; Sadgrove, Matthew P; Sueda, Katsuhiko; Yang, Yu-Tsai; Pacyniak, Erik K; Kagel, John R; Braun, Brenda A; Zamboni, William C; Mumper, Russell J; Jay, Michael

    2013-04-01

    Diethylenetriamine pentaacetic acid penta-ethyl ester, designated as C2E5, was successfully incorporated into a nonaqueous gel for transdermal delivery. The thermal and rheological properties of a formulation containing 40% C2E5, 20% ethyl cellulose, and 40% Miglyol 840® prepared using the solvent evaporation method demonstrated that the gel had acceptable content uniformity and flow properties. In vitro studies showed that C2E5 was steadily released from the gel at a rate suitable for transdermal delivery. Topical application of the gel at a 200 mg C2E5/kg dose level in rats achieved significantly higher plasma exposures of several active metabolites compared with neat C2E5 oil at the same dose level. The results suggest that transdermal delivery of a chelator prodrug is an effective radionuclide decorporation strategy by delivering chelators to the circulation with a pharmacokinetic profile that is more consistent with the biokinetic profile of transuranic elements in contaminated individuals.

  3. A randomized controlled trial evaluating antioxidant-essential oil gel as a treatment for gingivitis in orthodontic patients.

    PubMed

    Martin, Benjamin J; Campbell, Phillip M; Rees, Terry D; Buschang, Peter H

    2016-05-01

    To evaluate the treatment effect of an antioxidant-essential oil gel on orthodontic patients with generalized gingivitis. The gel contains the essential oils menthol and thymol and the antioxidants ferulic acid and phloretin. Thirty patients from the university's orthodontic clinic were screened for gingivitis and randomly allocated into treatment and placebo-control groups. Each patient was evaluated at three orthodontic treatment visits (T1, T2, and T3). A periodontal examination, including probing depth (PD), bleeding on probing (BOP), gingival index (GI), and plaque index (PI) was performed at each visit. Between T1 and T2, patients were instructed to apply a topical gel (active or placebo) to their gingiva twice daily after brushing. From T2 to T3, patients were instructed to discontinue use of the gel. The treatment group showed statistically significant (P < .05) reductions of BOP (-13.6 percentage points) and GI (-0.14) between T1 and T2, and significant increases in BOP (13.3 percentage points) and GI (0.14) between T2 and T3. Except for an increase in the GI between T2 and T3, the control group showed no significant changes in BOP or GI over time. The only other significant changes that occurred pertained to the treatment group, which showed significant increases in PD (0.08 mm) and PI (0.18) between T2 and T3. Application of a topical antioxidant-essential oil gel is an effective means of reducing inflammation in orthodontic patients with gingivitis.

  4. [Azelaic acid 15% gel in the treatment of acne vulgaris. Combined results of two double-blind clinical comparative studies].

    PubMed

    Gollnick, Harald P M; Graupe, Klaus; Zaumseil, Rolf-Peter

    2004-10-01

    Topical measures are still the mainstay in the therapy of mild-to-moderate acne vulgaris. Azelaic acid 20% in a cream formulation has been established as an efficacious and safe topical drug for 15 years. A new non-alcoholic hydrogel formulation containing 15% azelaic acid was clinically tested against two standard drugs--5% benzoyl peroxide (BPO) and 1% clindamycin. In two independent, randomized, blinded comparative trials 15% azelaic acid gel was clinically tested against 5% benzoyl peroxide (BPO) gel in 351 patients and against 1% clindamycin gel in 229 patients. The drugs were applied b.i.d. for 4 months. Azelaic acid 15% gel proved to be as effective as BPO and clindamycin with median % reduction of the inflamed lesion (papules and pustules) of 70%, and 71% respectively. The azelaic acid gel was well-tolerated, the side effects (local burning and irritation) were distinctly less than with BPO but more pronounced than with clindamycin. Despite these side effects, the treatment was well-accepted by the majority of patients. Azelaic acid gel is an effective topical monotherapy for mild-to-moderate acne vulgaris; its new gel form is an enrichment of acne therapy.

  5. PLMA vs. I-gel: A Comparative Evaluation of Respiratory Mechanics in Laparoscopic Cholecystectomy

    PubMed Central

    Sharma, Bimla; Sehgal, Raminder; Sahai, Chand; Sood, Jayashree

    2010-01-01

    Background: Supraglottic airway devices (SADs), such as ProSealTM laryngeal mask airway (PLMA), which produce high oropharyngeal seal pressure (OSP) and have the facility for gastric decompression have been used in laparoscopic procedures. i-gel is a new SAD which shares these features with the PLMA. This study was designed to compare the respiratory mechanics of these two devices during positive pressure ventilation in anaesthetised adult patients undergoing laparoscopic cholecystectomy. Patients & Methods: The study included 60 ASA I-II adult patients scheduled for laparoscopic cholecystectomy. The patients were randomized to two groups of 30 each, with either PLMA or i-gel as their airway device. Anaesthesia and premedication were standardized for both the groups. In addition to routine monitoring, neuromuscular monitoring with TOF ratio, OSP and respiratory mechanics monitoring (dynamic compliance, resistance, work of breathing, measured minute ventilation and peak airway pressures) were employed. Fibreoptic evaluation of positioning of the devices and adverse events related to them were also compared. Results: The OSP (cm H2O) were higher for PLMA (38.9 vs. 35.6, P=0.007). The respiratory mechanics parameters using the two devices were comparable apart from the dynamic compliance, which was significantly higher with i-gel (P < 0.05). Malrotation was higher with i-gel than with PLMA (15 vs. 5, P = 0.006). Conclusion: The PLMA formed a better seal while the dynamic compliance was higher with the i-gel. Both devices provided optimal ventilation and oxygenation and the adverse events were also comparable. PMID:21547168

  6. 40 CFR 86.007-23 - Required data.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 40 Protection of Environment 19 2013-07-01 2013-07-01 false Required data. 86.007-23 Section 86...-Fueled and Methanol-Fueled Heavy-Duty Vehicles § 86.007-23 Required data. Link to an amendment published... guidance see § 86.098-23. (c) Emission data—(1) Certification vehicles. The manufacturer shall submit...

  7. 40 CFR 86.007-21 - Application for certification.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 40 Protection of Environment 18 2010-07-01 2010-07-01 false Application for certification. 86.007-21 Section 86.007-21 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR... recirculation, the manufacturer must provide a detailed description of the control system the engine will use to...

  8. Directed shift of vaginal microbiota induced by vaginal application of sucrose gel in rhesus macaques.

    PubMed

    Hu, Kai-tao; Zheng, Jin-xin; Yu, Zhi-jian; Chen, Zhong; Cheng, Hang; Pan, Wei-guang; Yang, Wei-zhi; Wang, Hong-yan; Deng, Qi-wen; Zeng, Zhong-ming

    2015-04-01

    Sucrose gel was used to treat bacterial vaginosis in a phase III clinical trial. However, the changes of vaginal flora after treatment were only examined by Nugent score in that clinical trial, While the vaginal microbiota of rhesus macaques is characterized by anaerobic, Gram-negative bacteria, few lactobacilli, and pH levels above 4.6, similar to the microbiota of patients with bacterial vaginosis. This study is aimed to investigate the change of the vaginal microbiota of rehsus macaques after topical use of sucrose gel to reveal more precisely the bacterial population shift after the topical application of sucrose gel. Sixteen rhesus macaques were treated with 0.5 g sucrose gel vaginally and three with 0.5 g of placebo gel. Vaginal swabs were collected daily following treatment. Vaginal pH levels and Nugent scores were recorded. The composition of the vaginal micotbiota was tested by V3∼V4 16S rDNA metagenomic sequencing. Dynamic changes in the Lactobacillus genus were analyzed by qPCR. The vaginal microbiota of rhesus macaques are dominated by anaerobic Gram-negative bacteria, with few lactobacilli and high pH levels above 4.6. After five days' treatment with topical sucrose gel, the component percentage of Lactobacillus in vaginal microbiota increased from 1.31% to 81.59%, while the component percentage of Porphyromonas decreased from 18.60% to 0.43%, Sneathia decreased from 15.09% to 0.89%, Mobiluncus decreased from 8.23% to 0.12%, etc.. The average vaginal pH values of 16 rhesus macaques of the sucrose gel group decreased from 5.4 to 3.89. There were no significant changes in microbiota and vaginal pH observed in the placebo group. Rhesus macaques can be used as animal models of bacterial vaginosis to develop drugs and test treatment efficacy. Furthermore, the topical application of sucrose gel induced the shifting of vaginal flora of rhesus macaques from a BV kind of flora to a lactobacilli-dominating flora. Copyright © 2015 The Authors. Published by

  9. A Topical Hydrogel with Deferiprone and Gallium-Protoporphyrin Targets Bacterial Iron Metabolism and Has Antibiofilm Activity.

    PubMed

    Richter, Katharina; Thomas, Nicky; Claeys, Jolien; McGuane, Jonathan; Prestidge, Clive A; Coenye, Tom; Wormald, Peter-John; Vreugde, Sarah

    2017-06-01

    Many infectious diseases are associated with multidrug-resistant (MDR) bacteria residing in biofilms that require high antibiotic concentrations. While oral drug delivery is frequently ineffective, topical treatments have the potential to deliver higher drug concentrations to the infection site while reducing systemic side effects. This study determined the antibiofilm activity of a surgical wound gel loaded with the iron chelator deferiprone (Def) and the heme analogue gallium-protoporphyrin (GaPP), alone and in combination with ciprofloxacin. Activity against MDR Staphylococcus aureus , Staphylococcus epidermidis , Pseudomonas aeruginosa , and Acinetobacter johnsonii biofilms was assessed in the colony biofilm and artificial wound model by enumeration of CFU and correlative light/electron microscopy. While Staphylococcus biofilms were equally susceptible to GaPP and Def-GaPP gels (log 10 reduction of 3.8 and 3.7, respectively), the Def-GaPP combination was crucial for significant activity against P. aeruginosa biofilms (log 10 reduction of 1.3 for GaPP and 3.3 for Def-GaPP). When Def-GaPP gel was combined with ciprofloxacin, the efficacy exceeded the activity of the individual compounds. Def-GaPP delivered in a surgical wound gel showed significant antibiofilm activity against different MDR strains and could enhance the gel's wound-healing properties. Moreover, Def-GaPP indicated a potentiation of ciprofloxacin. This antibiofilm strategy has potential for clinical utilization as a therapy for topical biofilm-related infections. Copyright © 2017 American Society for Microbiology.

  10. A Topical Hydrogel with Deferiprone and Gallium-Protoporphyrin Targets Bacterial Iron Metabolism and Has Antibiofilm Activity

    PubMed Central

    Claeys, Jolien; McGuane, Jonathan; Prestidge, Clive A.; Wormald, Peter-John

    2017-01-01

    ABSTRACT Many infectious diseases are associated with multidrug-resistant (MDR) bacteria residing in biofilms that require high antibiotic concentrations. While oral drug delivery is frequently ineffective, topical treatments have the potential to deliver higher drug concentrations to the infection site while reducing systemic side effects. This study determined the antibiofilm activity of a surgical wound gel loaded with the iron chelator deferiprone (Def) and the heme analogue gallium-protoporphyrin (GaPP), alone and in combination with ciprofloxacin. Activity against MDR Staphylococcus aureus, Staphylococcus epidermidis, Pseudomonas aeruginosa, and Acinetobacter johnsonii biofilms was assessed in the colony biofilm and artificial wound model by enumeration of CFU and correlative light/electron microscopy. While Staphylococcus biofilms were equally susceptible to GaPP and Def-GaPP gels (log10 reduction of 3.8 and 3.7, respectively), the Def-GaPP combination was crucial for significant activity against P. aeruginosa biofilms (log10 reduction of 1.3 for GaPP and 3.3 for Def-GaPP). When Def-GaPP gel was combined with ciprofloxacin, the efficacy exceeded the activity of the individual compounds. Def-GaPP delivered in a surgical wound gel showed significant antibiofilm activity against different MDR strains and could enhance the gel's wound-healing properties. Moreover, Def-GaPP indicated a potentiation of ciprofloxacin. This antibiofilm strategy has potential for clinical utilization as a therapy for topical biofilm-related infections. PMID:28396543

  11. Valacyclovir and topical clobetasol gel for the episodic treatment of herpes labialis: a patient-initiated, double-blind, placebo-controlled pilot trial.

    PubMed

    Hull, C; McKeough, M; Sebastian, K; Kriesel, J; Spruance, S

    2009-03-01

    Treatment of herpes simplex labialis (HSL) has been associated with modest benefits. This difficulty results from the rapid resolution of the disease accomplished by the immune system, which narrows the window of therapeutic opportunity. The immune response is also responsible for important clinical manifestations, including oedema and pain. The dual role of immune responses (protection, pathology) is well recognized in other infectious diseases. The addition of corticosteroids to antimicrobial agents has been associated with improvement in some of these diseases. We evaluated the combination of oral valacyclovir plus topical clobetasol compared to placebo for recurrent HSL. Eighty-one subjects were screened, randomized, and dispensed medication (valacyclovir 2 g orally twice daily phiomicronrho 1 day and clobetasol gel 0.05% twice daily for 3 days). Forty-two patients developed a recurrence and initiated treatment. There were more aborted lesions in the valacyclovir-clobetasol arm compared to placebo-placebo (50% vs.15.8%, P = 0.04). Combination therapy reduced the mean maximum lesion size (9.7 vs. 54 mm(2), P = 0.002) and the mean healing time of classical lesions (5.8 vs. 9.3 days, P = 0.002). We created a composite statistic, area-under-the-curve (AUC) of classical lesion size versus time. There was a reduction in the AUC in the combination arm compared with placebo (23 vs. 193 mm(2), P < 0.001). Adverse events were minimal. Secondary and post-treatment recurrences were not increased by combination therapy. This pilot study supports the addition of topical corticosteroids to an oral antiviral agent for the treatment of HSL. Larger studies need to confirm the safety and efficacy of this approach.

  12. Reducing pain from palatal needle stick by topical anesthetics: a comparative study between two lidocaine/prilocaine substances.

    PubMed

    Al-Melh, Manal Abu; Andersson, Lars

    2008-01-01

    The aims of this study were to compare the topical anesthetic effect of two different preparations of lidocaine/prilocaine, cream versus thermosetting gel, on the reduction of pain from needle stick in the palate. The study also compared the subjects' preferences with regard to the substances. Two preparations of 2.5% lidocaine/2.5% prilocaine topical anesthetic agents were applied on the palatal mucosa in the canine region bilaterally and blindly to forty subjects. In the same visit, the cream (EMLA) was applied on one side and the thermosetting gel (Oraqix) on the other side, simultaneously. After that, a needle stick was given on each side using a 27-gauge needle inserted to bone contact through the palatal mucosa every second minute during a ten-minute period. Immediately after the needle stick, the subjects started recording their findings using a verbal scale, a visual analogue scale, and a questionnaire form. Significant differences were set at p < 0.05. Both substances reduced or eliminated pain from needle stick in the palate. Significant differences in pain reduction were observed between the two substances. EMLA reduced pain significantly better than Oraqix. With regard to comfort, taste, anesthetic effect, personal preference, and recommendation, the majority of the subjects favored the EMLA cream to the thermosetting gel. No adverse effects were reported by the subjects. Although both topical anesthetic agents are similar in content, the cream seemed to be preferred by the patients and reduced pain from needle stick in the palate significantly better than the thermosetting gel.

  13. Versatility of azelaic acid 15% gel in treatment of inflammatory acne vulgaris.

    PubMed

    Thiboutot, Diane

    2008-01-01

    Azelaic acid (AzA) 15% gel is approved for the treatment of rosacea in the US, but also has approval for the treatment of acne vulgaris in many European countries where it has demonstrated success. Two randomized, multicenter, controlled clinical trials compared the effects of AzA 15% gel with those of topical benzoyl peroxide 5% or topical clindamycin 1%, all using a twice-daily dosing regimen. The primary endpoint in the intent-to-treat analysis was a reduction in inflammatory papules and pustules. AzA 15% gel resulted in a 70% to 71% median reduction of facial papules and pustules compared with a 77% reduction with benzoyl peroxide 5% gel and a 63% reduction with clindamycin. AzA 15% gel was well-tolerated. In addition, a 1-year European observational study conducted by dermatologists in private practice evaluated the safety and efficacy of AzA 15% gel used as monotherapy or in combination with other agents in more than 1200 patients with acne. Most physicians (81.9%) described an improvement in patients' symptoms after an average of 34.6 days, and 93.9% of physicians reported patient improvement after an average of 73.1 days. Both physicians and patients assessed AzA 15% gel to be effective with 74% of patients being "very satisfied" at the end of therapy. AzA 15% gel was considered "well-tolerated" or "very well-tolerated" by 95.7% of patients. The majority of patients were more satisfied with AzA than with previous therapies. AzA 15% gel represents a new therapeutic option for the treatment of acne vulgaris.

  14. Talcum powder or aqueous gel to aid external cephalic version: a randomised controlled trial

    PubMed Central

    2014-01-01

    Background External cephalic version (ECV) is offered to reduce the number of Caesarean delivery indicated by breech presentation which occurs in 3-4% of term pregnancies. ECV is commonly performed aided by the application of aqueous gel or talcum powder to the maternal abdomen. We sought to compare gel with powder during ECV on achieving successful version and increasing tolerability. Method We enrolled 95 women (≥ 36 weeks gestation) on their attendance for planned ECV. All participants received terbutaline tocolysis. Regional anaesthesia was not used. ECV was performed in the standard fashion after the application of the allocated aid. If the first round (maximum of 2 attempts) of ECV failed, crossover to the opposing aid was permitted. Results 48 women were randomised to powder and 47 to gel. Self-reported procedure related median [interquartile range] pain scores (using a 10-point visual numerical rating scale VNRS; low score more pain) were 6 [5-9] vs. 8 [7-9] P = 0.03 in favor of gel. ECV was successful in 21/48 (43.8%) vs. 26/47 (55.3%) RR 0.6 95% CI 0.3-1.4 P = 0.3 for powder and gel arms respectively. Crossover to the opposing aid and a second round of ECV was performed in 13/27 (48.1%) following initial failure with powder and 4/21 (19%) after failure with gel (RR 3.9 95% CI 1.0-15 P = 0.07). ECV success rate was 5/13 (38.5%) vs. 1/4 (25%) P = 0.99 after crossover use of gel or powder respectively. Operators reported higher satisfaction score with the use of gel (high score, greater satisfaction) VNRS scores 6 [4.25-8] vs 8 [7-9] P = 0.01. Conclusion Women find gel use to be associated with less pain. The ECV success rate is not significantly different. Trial registration The trial is registered with ISRCTN (identifier ISRCTN87231556). PMID:24468078

  15. 48 CFR 1535.007 - Solicitations.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... OF CONTRACTING RESEARCH AND DEVELOPMENT CONTRACTING 1535.007 Solicitations. (a) Contracting officers... Confidential Business Information, in all solicitations when the contracting officer has determined that EPA may furnish the contractor with confidential business information which EPA had obtained from third...

  16. 48 CFR 35.007 - Solicitations.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... offeror's experience; (5) Pertinent novel ideas in the specific branch of science and technology involved...). (i) In circumstances when a concern has a new idea or product to discuss that incorporates the... CONTRACTING RESEARCH AND DEVELOPMENT CONTRACTING 35.007 Solicitations. (a) The submission and subsequent...

  17. 48 CFR 35.007 - Solicitations.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... offeror's experience; (5) Pertinent novel ideas in the specific branch of science and technology involved...). (i) In circumstances when a concern has a new idea or product to discuss that incorporates the... CONTRACTING RESEARCH AND DEVELOPMENT CONTRACTING 35.007 Solicitations. (a) The submission and subsequent...

  18. Topical herbal therapies for treating osteoarthritis

    PubMed Central

    Cameron, Melainie; Chrubasik, Sigrun

    2014-01-01

    Background Before extraction and synthetic chemistry were invented, musculoskeletal complaints were treated with preparations from medicinal plants. They were either administered orally or topically. In contrast to the oral medicinal plant products, topicals act in part as counterirritants or are toxic when given orally. Objectives To update the previous Cochrane review of herbal therapy for osteoarthritis from 2000 by evaluating the evidence on effectiveness for topical medicinal plant products. Search methods Databases for mainstream and complementary medicine were searched using terms to include all forms of arthritis combined with medicinal plant products. We searched electronic databases (Cochrane Central Register of Controlled Trials (CENTRAL),MEDLINE, EMBASE, AMED, CINAHL, ISI Web of Science, World Health Organization Clinical Trials Registry Platform) to February 2013, unrestricted by language. We also searched the reference lists from retrieved trials. Selection criteria Randomised controlled trials of herbal interventions used topically, compared with inert (placebo) or active controls, in people with osteoarthritis were included. Data collection and analysis Two review authors independently selected trials for inclusion, assessed the risk of bias of included studies and extracted data. Main results Seven studies (seven different medicinal plant interventions; 785 participants) were included. Single studies (five studies, six interventions) and non-comparable studies (two studies, one intervention) precluded pooling of results. Moderate evidence from a single study of 174 people with hand osteoarthritis indicated that treatment with Arnica extract gel probably results in similar benefits as treatment with ibuprofen (non-steroidal anti-inflammatory drug) with a similar number of adverse events. Mean pain in the ibuprofen group was 44.2 points on a 100 point scale; treatment with Arnica gel reduced the pain by 4 points after three weeks: mean difference (MD

  19. Azelaic acid (15% gel) in the treatment of acne rosacea.

    PubMed

    Gupta, Aditya K; Gover, Melissa D

    2007-05-01

    In December of 2002, the FDA approved azelaic acid 15% gel for the topical treatment of inflammatory papules and pustules of mild to moderate rosacea. Azelaic acid is a saturated dicarboxylic acid, which is naturally occurring and has been used in the treatment of rosacea, acne, and melasma. The 15% gel has a high efficacy and is generally well tolerated, with the local irritation (burning, stinging, itching, and scaling) being typically mild and transient. Azelaic acid 15% gel is considered effective and safe as a therapy for inflammatory papulo-pustular rosacea and is suitable for use on all skin types.

  20. An in vivo and in vitro investigation of the effect of Aloe vera gel ethanolic extract using animal model with diabetic foot ulcer

    PubMed Central

    Daburkar, Mohan; Lohar, Vikram; Rathore, Arvind Singh; Bhutada, Pravin; Tangadpaliwar, Shrikant

    2014-01-01

    Aim: To examine the preventive effect of Aloe vera gel ethanolic extract using diabetic foot ulcer (DFUs) protocol in Wistar rats. Materials and Methods: Male Wistar rats were divided into untreated control (Group I), untreated DFUs (Group II), DFUs treated with A. vera gel ethanolic extract (Group III), DFUs treated with topical A. vera gel (Group IV), DFUs treated with A. vera gel ethanolic extract and topical A. vera gel (Group V). The rats in the treatment groups were daily administered the A. vera gel and ethanolic extract for 9 days. Fasting blood glucose levels and percentage of wound ulcer contraction were measured on day 3, 6, and 9. Statistical Analysis used: The results are expressed as a mean ± Standard Error Mean (SEM). Data were analyzed using one-way analysis of variance (ANOVA) after Newman–Keuls test. P < 0.05 were considered statistically significant in all cases. Results: Oral administration of A. vera gel ethanolic extract at a dose of 300 mg/kg body weight per day to diabetic rats for a period of 9 days resulted in a significant reduction in fasting blood glucose and a significant improvement in plasma insulin. Topical application of A. vera gel at a dose 30 mg/kg body weight per day to streptozotocin (STZ)-induced diabetic rats for a period of 9 days resulted in no change in blood glucose and plasma insulin. Oral administration as well as topical application of A. vera gel ethanolic extract and gel significantly reduced the blood glucose, improved the plasma insulin, and significantly increased DNA and glycosaminoglycans (GAGs) to improve the wound ulcer healing as well as the breaking strength on day 9. Conclusions: Present findings provide a scientific rationale for the use of A. vera gel ethanolic extract, and showed that the gel attenuated the diabetic foot wound in rats. PMID:25035641

  1. Ganciclovir ophthalmic gel 0.15% for the treatment of acute herpetic keratitis: background, effectiveness, tolerability, safety, and future applications

    PubMed Central

    Chou, Timothy Y; Hong, Bennett Y

    2014-01-01

    Eye disease due to herpes simplex virus (HSV) is a leading cause of ocular morbidity and the number one infectious cause of unilateral corneal blindness in the developed parts of the globe. Recurrent keratitis can result in progressive corneal scarring, thinning, and vascularization. Antiviral agents employed against HSV have primarily been nucleoside analogs. Early generation drugs included idoxuridine, iododesoxycytidine, vidarabine, and trifluridine. While effective, they tended to have low bioavailability and measurable local cellular toxicity due to their nonselective mode of action. Acyclovir 0.3% ointment is a more selective agent, and had become a first-line topical drug for acute HSV keratitis in Europe and other places outside of the US. Ganciclovir 0.15% gel is the most recently approved topical treatment for herpes keratitis. Compared to acyclovir 0.3% ointment, ganciclovir 0.15% gel has been shown to be better tolerated and no less effective in several Phase II and III trials. Additionally, topical ganciclovir does not cause adverse systemic side effects and is therapeutic at lower concentrations. Based on safety, efficacy, and tolerability, ganciclovir 0.15% gel should now be considered a front-line topical drug in the treatment of dendritic herpes simplex epithelial keratitis. Topics of future investigation regarding other potential uses for ganciclovir gel may include the prophylaxis of recurrent HSV epithelial keratitis, treatment of other forms of ocular disease caused by herpesviruses and adenovirus, and ganciclovir gel as an adjunct to antitumor therapy. PMID:25187721

  2. Hydroxychloroquine niosomes: a new trend in topical management of oral lichen planus.

    PubMed

    Bendas, Ehab R; Abdullah, Hamoud; El-Komy, Mohamed H M; Kassem, Mohamed A A

    2013-12-31

    The work aimed at studying a novel topical niosomal gel formulation of hydroxychloroquine for the management of oral lichen planus. Niosomes have been reported as conceivable vesicles to deliver drug molecules to the desired mucous membrane or skin layers. Hydroxychloroquine niosomes were designed using different methods of preparation. Tween 20 and cholesterol in molar ratio (1:0.5) were used. The prepared systems were characterized for entrapment efficiency, particle size and in vitro drug release. Different factors affecting the encapsulation of hydroxychloroquine in niosomes were studied vs. varying the type of surfactant, the cholesterol:surfactant molar ratio and the amount of the drug. The selected noisome formulation was dispersed in different gel formulations and evaluated according to the in vitro drug release and the physical stability. The results showed that the type of surfactant, cholesterol ratio and incorporated amount of drug altered the entrapment efficiency and the in vitro release of hydroxychloroquine from niosomes. The optimum formulation was prepared by reverse phase evaporation technique using Brij 98:cholesterol molar ratio (1:1.5) and containing 20mg of hydroxychloroquine and incorporated in 20% w/v Pluronic F-127 gel. A double-blind, controlled clinical study was performed using two groups of patients. Group A (n=11) who received hydroxychloroquine niosomal gel formulation, one application-a-day over 4 months showed 64.28% reduction in the size of lesions and the average score of pain was reduced from "4" to "1". Compared to placebo group B (n=5), who showed only 3.94% reduction in the lesion size and the average score of pain was remained "3". Our results suggest that these niosomal formulations could constitute a promising approach for the topical treatment of oral lichen planus in short time with less side effects and no recurrence after stopping the treatment. Copyright © 2013 Elsevier B.V. All rights reserved.

  3. Fabrication of topical metered dose film forming sprays for pain management.

    PubMed

    Ranade, Sneha; Bajaj, Amrita; Londhe, Vaishali; Babul, Najib; Kao, Danny

    2017-03-30

    Topical film-forming metered dose spray formulations were designed for management of pain. Ropivacaine, a local anesthetic is explored for its topical efficacy in alleviating pain. Metered dose spray containers, organic solvents, film forming polymers and permeation enhancers were utilized to fabricate the Metered Dose topical spray. Factors like viscosity, spray pattern, spray angle, volume of actuation, droplet size distribution of the metered dose spray formulation and drying time, flexibility and wash-ability of the film formed after spraying were assessed. Permeation of the drug into the porcine skin was observed based on ex-vivo diffusion studies and confocal microscopy. The results indicated a high level of drug concentration in the skin layers. Anti-nociceptive efficacy of the formulations was assessed on Wistar rats by hot plate and tail flick tests, based on the response to pain perception. The results were comparable to the conventional lidocaine gel. Topical film forming sprays have the ability to provide an accurate, long lasting and patient compliant delivery of drugs on the skin as compared to conventional gels. Copyright © 2017 Elsevier B.V. All rights reserved.

  4. Efficacy and safety of once-daily metronidazole 1% gel compared with twice-daily azelaic acid 15% gel in the treatment of rosacea.

    PubMed

    Wolf, John E; Kerrouche, Nabil; Arsonnaud, Stephanie

    2006-04-01

    Rosacea is an inflammatory dermatologic disorder characterized by the presence of facial erythema, visible blood vessels, papules, and pustules. The National Rosacea Society has established a classification system that identifies 4 distinct rosacea subtypes based on clinical presentation: erythematotelangiectatic, papulopustular, phymatous, and ocular. The goal of topical therapy for rosacea is to reduce inflammatory lesion counts; decrease intensity of erythema; and reduce symptoms such as stinging, burning, and pruritus. Metronidazole and azelaic acid are thought to reduce the inflammation associated with rosacea by inhibiting the production of reactive oxygen species produced by neutrophils. Both metronidazole 1% gel and azelaic acid 15% gel recently have been approved for the treatment of rosacea. The current study was conducted to compare the once-daily application of metronidazole 1% gel with twice-daily applications of azelaic acid 15% gel for the treatment of patients with moderate rosacea (N=160). Both treatments showed similar reductions in inflammatory lesion counts (77% for metronidazole 1% gel and 80% for azelaic acid 15% gel) and high success rates in both global severity (53.7% vs 56.4% for metronidazole 1% gel and azelaic acid 15% gel, respectively) and erythema (42.7% vs 42.3% for metronidazole 1% gel and azelaic acid 15% gel, respectively). On average, the efficacy (including reduction in erythema) of the once-daily application of metronidazole 1% gel and twice-daily applications of azelaic acid 15% gel were similar.

  5. Aloe vera gel and thyroid hormone cream may improve wound healing in Wistar rats

    PubMed Central

    Norouzian, Mohsen; Zarein-Dolab, Saeed; Dadpay, Masoomeh; Mohsenifar, Jaleh; Gazor, Roohollah

    2012-01-01

    Therapeutic effects of various treatment options in wound healing have been one of the most controversial issues in surgical science. The present study was carried out to examine and compare the effects of Aloe vera gel, thyroid hormone cream and silver sulfadiazine cream onsutured incisions in Wistar rats. In a randomized controlled trial, thirty-six Wistar male rats, 250 to 300 g, received surgical incisions followed by topical application of Aloe vera gel, thyroid hormone cream and silver sulfadiazine 1%. To assess the efficacy of each treatment technique, a histological approach was used to evaluate the mean number of fibroblasts, macrophages, neutrophils, blood vessel sections and thickness of the regenerating epithelium and dermis on days 4, 7 and 14. Re-epithelialization and angiogenesis were significantly improved in Aloe vera gel group compared with the other treatments while thyroid hormone cream had positive effects on day 4 (P≤0.05). Topical administration of Aloe vera gel is recommended as the treatment of choice for surgical incisions. PMID:23094205

  6. On the development of a VIPARnd radiotherapy 3D polymer gel dosimeter

    NASA Astrophysics Data System (ADS)

    Kozicki, Marek; Jaszczak, Malwina; Maras, Piotr; Dudek, Mariusz; Cłapa, Marian

    2017-02-01

    This work presents an improvement of the VIPARnd (‘nd’ stands for ‘normoxic, double’, or VIP) polymer gel dosimeter. The gel composition was altered by increasing the concentration of the monomeric components, N-vinylpyrrolidone (NVP) and N,N‧-methylenebisacrylamide (MBA), in co-solvent solutions. The optimal composition (VIPARCT, where ‘CT’ stands for computed tomography, or VIC) comprised: 17% NVP, 8% MBA, 12% t-BuOH, 7.5% gelatine, 0.007% ascorbic acid, 0.0008% CuSO4  ×  5H2O and 0.02% hydroquinone. The following characteristics of VIC were achieved: (i) linear dose range of 0.9_30 Gy, (ii) saturation for radiation doses of over 50 Gy, (iii) threshold dose of about 0.5 Gy, (iv) dose sensitivity of 0.171 Gy-1 s-1, which is roughly 2.2 times higher than that of VIP (for nuclear magnetic resonance measurements). It was also found that VIC is dose- rate-independent, and its dose response does not alter if the radiation source is changed from electrons to photons for external beam radiotherapy. The gel responded similarly to irradiation with small changes in radiation energy but was sensitive to larger energy changes. The VIC gel retained temporal stability from 20 h until at least 10 d after irradiation, whereas spatial stability was retained from 20 h until at least 6 d after irradiation. The scheme adopted for VIC manufacturing yields repeatable gels in terms of radiation dose response. The VIC was also shown to perform better than VIP using x-ray computed tomography as a readout method; the dose sensitivity of VIC (0.397 HU Gy-1) was 1.5 times higher than that of VIP. Also, the dose resolution of VIC was better than that of VIP in the whole dose range examined.

  7. Pharmacokinetic Studies of Gel System Containing Ibuprofen Solid Nanoparticles.

    PubMed

    Nagai, Noriaki; Tanino, Tadatoshi; Ito, Yoshimasa

    2016-12-01

    In the therapy of rheumatoid arthritis, ibuprofen (IBU) is widely used; however, it has been limited the clinical use by its systemic side effect, such as gastrointestinal lesions. Therefore, we prepared topical gel ointment used IBU solid nanoparticles (IBU nano -gel formulation). In addition, we demonstrated their anti-inflammatory effect by using arthritis model rat (adjuvant-induced arthritis rat, AA rat). The gel formulations were prepared using additives (Carbopol 934, 2-hydroxypropyl-β-cyclodextrin and methylcellulose) and bead mill-method. The IBU particle size in the IBU nano -gel formulation was 208 nm. The increase in inflammation of the hind feet of AA rats was attenuated by the treatment with the IBU nano -gel formulation, and preventive effect was higher than that of a gel formulation containing IBUmicroparticles (IBU micro -gel formulation, mean particle size 85.4 μm); the accumulation and permeability through the skin of IBU from the IBU nano -gel formulation were significantly larger in comparison with the IBU micro -gel formulation. Further, no gastrointestinal lesions were observed in AA rats following the repetitive administration of the 5% IBU nano -gel formulation (0.30 g) for 42 days (once a day). These results suggest that the dermal application of IBU-nanoparticles provide effective and efficient therapy that spares patients from unwanted side effects.

  8. Clindamycin phosphate-tretinoin combination gel revisited: status report on a specific formulation used for acne treatment.

    PubMed

    Del Rosso, James Q

    2017-03-01

    Topical agents, including retinoids and antibiotics, are commonly used to treat acne vulgaris (AV) and remain as components of acne treatment guidelines. Approved topical combination formulations offer the advantages of established efficacy, decreased frequency of application, and improved convenience for patients. This article discusses both clindamycin phosphate (CP) and tretinoin (Tret) as components of a topical aqueous-based combination gel that has been shown to be effective, safe, and well tolerated for treatment of facial AV. Clinically relevant considerations with use of this treatment are also discussed, including therapeutic advantages and potential limitations.

  9. Anti-inflammatory and Analgesic Activities of Topical Formulations of Pterocarpus Santalinus Powder in Rat Model of Chronic Inflammation.

    PubMed

    Dhande, Priti Pravin; Gupta, Amit O; Jain, Sourav; Dawane, Jayshree Shriram

    2017-07-01

    The incidence of arthritis is quite high and there is a need for the search of natural products to halt the progression of disease or provide symptomatic relief without significant adverse effects. This study aimed at evaluating the anti-inflammatory and analgesic activities of topical Pterocarpus santalinus in an animal model of chronic inflammation. Albino rats of either sex were divided into five groups of six rats each (Group I - Control, Group II -Gel base, Group III - P. santalinus paste, Group IV - P. santalinus gel, Group V- Diclofenac gel). Chronic inflammation was induced on day 0 by injecting 0.1 ml Complete Freund's Adjuvant (CFA) in sub-plantar tissue of left hind paw of the rats. Topical treatment was started from day 12 till day 28. Body weight and paw volume (Plethysmometer) were assessed on day 0, 12 and 28. Pain assessment was done using Randall and Selitto paw withdrawal method. Data was analysed using GraphPad Prism version 5. Unpaired students t-test and ANOVA followed by Tukey's test was used for comparison among groups. Only topical P.santalinus gel significantly reduced the body weight (p=0.02) due to reduction in inflammatory oedema of the left limb. P. santalinus gel also showed significant reduction (p=0.03) in paw volume of rats compared to the other groups. There was significant reduction in pain threshold (gm/sec) due to chronic inflammation, with all the study drugs (p<0.05) but with P. santalinus gel, this reduction was less (p<0.001). Gel showed significant anti-inflammatory and mild analgesic activity on topical application in rat model of chronic inflammation.

  10. Accelerated re-epithelialization of partial-thickness skin wounds by a topical betulin gel: Results of a randomized phase III clinical trials program.

    PubMed

    Barret, Juan P; Podmelle, Fred; Lipový, Břetislav; Rennekampff, Hans-Oliver; Schumann, Hauke; Schwieger-Briel, Agnes; Zahn, Tobias R; Metelmann, Hans-Robert

    2017-09-01

    The clinical significance of timely re-epithelialization is obvious in burn care, since delayed wound closure is enhancing the risk of wound site infection and extensive scarring. Topical treatments that accelerate wound healing are urgently needed to reduce these sequelae. Evidence from preliminary studies suggests that betulin can accelerate the healing of different types of wounds, including second degree burns and split-thickness skin graft wounds. The goal of this combined study program consisting of two randomized phase III clinical trials in parallel is to evaluate whether a topical betulin gel (TBG) is accelerating re-epithelialization of split-thickness skin graft (STSG) donor site wounds compared to standard of care. Two parallel blindly evaluated, randomised, controlled, multicentre phase III clinical trials were performed in adults undergoing STSG surgery (EudraCT nos. 2012-003390-26 and 2012-000777-23). Donor site wounds were split into two equal halves and randomized 1:1 to standard of care (a non-adhesive moist wound dressing) or standard of care plus TBG consisting of 10% birch bark extract and 90% sunflower oil (Episalvan, Birken AG, Niefern-Oeschelbronn, Germany). The primary efficacy assessment was the intra-individual difference in time to wound closure assessed from digital photographs by three blinded experts. A total of 219 patients were included and treated in the two trials. Wounds closed faster with TBG than without it (15.3 vs. 16.5 days; mean intra-individual difference=-1.1 days [95% CI, -1.5 to -0.7]; p<0.0001). This agreed with unblinded direct clinical assessment (difference=-2.1 days [95% CI, -2.7 to -1.5]; p<0.0001). Adverse events possibly related to treatment were mild or moderate and mostly at the application site. TBG accelerates re-epithelialization of partial thickness wounds compared to the current standard of care, providing a well-tolerated contribution to burn care in practice. Copyright © 2017 The Authors. Published by

  11. Development and evaluation of nanostructured lipid carrier-based hydrogel for topical delivery of 5-fluorouracil

    PubMed Central

    Rajinikanth, Paruvathanahalli Siddalingam; Chellian, Jestin

    2016-01-01

    The aim of this study was to develop a nanostructured lipid carrier (NLC)-based hydrogel and study its potential for the topical delivery of 5-fluorouracil (5-FU). Precirol® ATO 5 (glyceryl palmitostearate) and Labrasol® were selected as the solid and liquid lipid phases, respectively. Poloxamer 188 and Solutol® HS15 (polyoxyl-15-hydroxystearate) were selected as surfactants. The developed lipid formulations were dispersed in 1% Carbopol® 934 (poly[acrylic acid]) gel medium in order to maintain the topical application consistency. The average size, zeta potential, and polydispersity index for the 5-FU-NLC were found to be 208.32±8.21 nm, −21.82±0.40 mV, and 0.352±0.060, respectively. Transmission electron microscopy study revealed that 5-FU-NLC was <200 nm in size, with a spherical shape. In vitro drug permeation studies showed a release pattern with initial burst followed by sustained release, and the rate of 5-FU permeation was significantly improved for 5-FU-NLC gel (10.27±1.82 μg/cm2/h) as compared with plain 5-FU gel (2.85±1.12 μg/cm2/h). Further, skin retention studies showed a significant retention of 5-FU from the NLC gel (91.256±4.56 μg/cm2) as compared with that from the 5-FU plain gel (12.23±3.86 μg/cm2) in the rat skin. Skin irritation was also significantly reduced with 5-FU-NLC gel as compared with 5-FU plain gel. These results show that the prepared 5-FU-loaded NLC has high potential to improve the penetration of 5-FU through the stratum corneum, with enormous retention and with minimal skin irritation, which is the prerequisite for topically applied formulations. PMID:27785014

  12. Coupled gel spreading and diffusive transport models describing microbicidal drug delivery

    NASA Astrophysics Data System (ADS)

    Funke, Claire; MacMillan, Kelsey; Ham, Anthony S.; Szeri, Andrew J.; Katz, David F.

    2016-11-01

    Gels are a drug delivery platform being evaluated for application of active pharmaceutical ingredients, termed microbicides, that act topically against infection by sexually transmitted HIV. Despite success in one Phase IIb trial of a vaginal gel delivering tenofovir, problems of user adherence to designed gel application regimen compromised results in two other trials. The microbicide field is responding to this issue by simultaneously analyzing behavioral determinants of adherence and pharmacological determinants of drug delivery. Central to both user adherence and mucosal drug delivery are gel properties (e.g. rheology) and applied volume. The specific problem to be solved here is to develop a model for how gel rheology and volume, interacting with loaded drug concentration, govern the transport of the microbicide drug tenofovir into the vaginal mucosa to its stromal layer. The analysis here builds upon our current understanding of vaginal gel deployment and drug delivery, incorporating key features of the gel's environment, fluid production and subsequent gel dilution, and vaginal wall elasticity. We consider the microbicide drug tenofovir as it is the most completely studied drug, in both in vitroand in vivostudies, for use in vaginal gel application. Our goal is to contribute to improved pharmacological understanding of gel functionality, providing a computational tool that can be used in future vaginal microbicide gel design.

  13. Azelaic acid gel 15% in the management of papulopustular rosacea: a status report on available efficacy data and clinical application.

    PubMed

    Del Rosso, James Q; Bhatia, Neal

    2011-08-01

    Azelaic acid (AzA) gel 15% is approved by the US Food and Drug Administration (FDA) for the treatment of papulopustular rosacea (PPR). Its efficacy and safety as monotherapy have been demonstrated. Release of active drug from the gel formulation is superior to the cream. The combination of AzA gel 15% with oral doxycycline appears to expedite and augment response, especially in cases of PPR of greater severity, and AzA gel 15% maintains control of PPR over 6 months as compared to vehicle. Adjunctive skin care is recommended to augment the therapeutic outcome of PPR and reduce the potential for irritation that can occur with topical therapy.

  14. Topical modalities for treatment and prevention of postsurgical hypertrophic scars.

    PubMed

    Foo, Chong Wee; Tristani-Firouzi, Payam

    2011-08-01

    There is no universally accepted treatment regimen and no evidence-based literature to guide management of hypertrophic scars. This article summarizes the existing literature regarding topical treatments such as silicone gel sheeting and ointment, onion extract, vitamin E, pressure garment therapy, massage therapy, and topical imiquimod 5% cream in the management of hypertrophic scars. 2011 Elsevier Inc. All rights reserved.

  15. Antipsoriatic and Anti-inflammatory Studies of Berberis aristata Extract Loaded Nanovesicular Gels

    PubMed Central

    Nimisha; Rizvi, Dilshad Ali; Fatima, Zeeshan; Neema; Kaur, Chanchal Deep

    2017-01-01

    Objective: Novel nanovesicular gel of Berberis aristata extract was developed and evaluated for its anti-inflammatory and antipsoriatic activity. Materials and Methods: Transferosomes were prepared using soya phosphatidylcholine and edge activators (Tween 80, Span 80, and sodium deoxycholate) by a modified lipid film hydration technique using rotary evaporator and evaluated for various parameters. The quantification and standardization of extract have been carried out using its alkaloid content as berberine as biomarker. Topical application of imiquimod (IMQ) (immune modifier) on the shaved back of mice developed psoriasis-like inflammation followed by histopathological study of inflamed skin. Results: The size of transferosomes was in the range of 265–345 nm whereas polydispersity index ranges from 0.10 to 0.63, and for zeta potential, it was from −19.3 to −43.3 mV. Transferosomes were further added to Carbopol 934P for gel formation and subsequently evaluated for their physicochemical properties. Their efficacy against inflammation, IMQ-induced psoriasis, and skin sensitivity was compared with conventional formulation (commercial formulation-Angle Gloss, Phytolab Pvt. Ltd.). Percent inhibition of edema by transferosomal gel (55.76%) was more as compared to conventional gel of extract (33.5%) found out by Carrageenan-induced paw edema method. Primary irritation index was found to be <0.4 inferring its safe use for topical formulation. Conclusion: Histopathological report showed that, in psoriasis-induced animal treated with topical application of extract loaded transferosomal gel showed a marked reduction in thickness of epidermis, length of rete ridges as compared to conventional gel formulation. It can be inferred that B. aristata extract loaded transferosomal gel can function as potential anti-inflammatory and antipsoriatic formulation. SUMMARY The objective of the present research work was to prepare Berberis aristata extracts (roots, ethanolic 70%v

  16. The effect on acne quality of life of topical azelaic acid 15% gel versus a combined oral contraceptive in adult female acne: A randomized trial.

    PubMed

    Rocha, Marco; Sanudo, Adriana; Bagatin, Edileia

    2017-01-01

    Acne vulgaris is a chronic inflammatory disease that affects the pilosebaceous unit. Recent studies have shown an increasing number of cases of acne in adult women. These cases are predominantly normoandrogenic and have show some clinical differences compared to adolescent acne. In addition to the physical aspects, acne has a strong psychosocial impact and can lead to the onset of signs and symptoms of depression, such as anger. Our objective was to evaluate the effect on acne-specific quality of life in adult women treated with topical azelaic acid versus a combined oral contraceptive. The study population consisted of 38 adult women with acne and without any features of hyperandrogenism recruited from the clinic of Dermatology Hospital Division of São Paulo, Federal University of São Paulo from January 2012 to September 2014. Patients were randomized into two different groups: one receiving containing 20 ug of ethinylestradiol and 3 mg drospirenone in a regimen of 24 days of medication, a combined oral contraceptive (COC), and the other group topical 15% azelaic acid (AA) gel, twice daily, both for six months. The quality of life was evaluated at baseline and end of treatment with an acne specific measure (Acne-QoL). Before treatment, our data revealed a significant impact of the presence of acne on quality of life. Both treatments resulted in improvement with significant statistical values in quality of life scores. Comparing the four domains of Acne-QoL, patients treated with an oral contraceptive showed greater improvement in two domains (self-perception and acne symptoms) than those treated with azelaic acid.

  17. Pluronic lecithin organogel as a topical drug delivery system.

    PubMed

    Pandey, Mohit; Belgamwar, Veena; Gattani, Surendra; Surana, Sanjay; Tekade, Avinash

    2010-01-01

    The objective of this study was to formulate and evaluate the pluronic lecithin organogel containing flurbiprofen for topical application. Different formulations of pluronic lecithin organogels were prepared by using pluronic F127, lecithin, flurbiprofen, isopropyl palmitate, water, sorbic acid, and potassium sorbate. To study the in vitro potential of these formulations, permeation studies were performed with Keshary-Chien diffusion cells. The results of the in vitro permeation studies found that release of flurbiprofen from dialysis membrane-70 was more than excised dorsal rat skin. Gelation temperature study was carried out to determine the temperature where sol-gel transformation takes place. The viscosities of different formulations were determined by using Brookfield Viscometer at 25°C, the viscosity of formulations increases as the lecithin concentration increases. Also the formulations were tested for appearance and feel psychorheologically, pH, and drug content. Interactions between the components of the gel have been investigated by differential scanning calorimetry and X-ray powder diffractometry. The optimized formulation subjected to differential scanning calorimetry shows no drug-polymer interaction. To investigate the in vivo performance of the formulations, a carrageenan-induced rat paw edema model and skin irritation study was used. The stability studies and freeze-thaw thermal cyclic test were carried out, showing no phase separation of gel, and representing gel stability. Statistical analysis of the data of animal study (anti-inflammatory activity) was done by using one way analysis of variance (ANOVA) followed by Dunnett's test. The formulation shows a statistically significant anti-inflammatory activity and is non-irritant to skin.

  18. Anti-inflammatory and Analgesic Activities of Topical Formulations of Pterocarpus Santalinus Powder in Rat Model of Chronic Inflammation

    PubMed Central

    Gupta, Amit O; Jain, Sourav; Dawane, Jayshree Shriram

    2017-01-01

    Introduction The incidence of arthritis is quite high and there is a need for the search of natural products to halt the progression of disease or provide symptomatic relief without significant adverse effects. Aim This study aimed at evaluating the anti-inflammatory and analgesic activities of topical Pterocarpus santalinus in an animal model of chronic inflammation. Materials and Methods Albino rats of either sex were divided into five groups of six rats each (Group I – Control, Group II –Gel base, Group III –P. santalinus paste, Group IV –P. santalinus gel, Group V– Diclofenac gel). Chronic inflammation was induced on day 0 by injecting 0.1 ml Complete Freund’s Adjuvant (CFA) in sub-plantar tissue of left hind paw of the rats. Topical treatment was started from day 12 till day 28. Body weight and paw volume (Plethysmometer) were assessed on day 0, 12 and 28. Pain assessment was done using Randall and Selitto paw withdrawal method. Data was analysed using GraphPad Prism version 5. Unpaired students t-test and ANOVA followed by Tukey’s test was used for comparison among groups. Results Only topical P.santalinus gel significantly reduced the body weight (p=0.02) due to reduction in inflammatory oedema of the left limb. P. santalinus gel also showed significant reduction (p=0.03) in paw volume of rats compared to the other groups. There was significant reduction in pain threshold (gm/sec) due to chronic inflammation, with all the study drugs (p<0.05) but with P. santalinus gel, this reduction was less (p<0.001). Conclusion Gel showed significant anti-inflammatory and mild analgesic activity on topical application in rat model of chronic inflammation. PMID:28892928

  19. Nanostructured lipid carriers (NLCs) versus solid lipid nanoparticles (SLNs) for topical delivery of meloxicam.

    PubMed

    Khalil, Rawia M; Abd-Elbary, A; Kassem, Mahfoz A; Ghorab, Mamdouh M; Basha, Mona

    2014-05-01

    The aim of this study was to develop nanostructured lipid carriers (NLCs) as well as solid lipid nanoparticles (SLNs) and evaluate their potential in the topical delivery of meloxicam (MLX). The effect of various compositional variations on their physicochemical properties was investigated. Furthermore, MLX-loaded lipid nanoparticles-based hydrogels were formulated and the gels were evaluated as vehicles for topical application. The results showed that NLC and SLN dispersions had spherical shapes with an average size between 215 and 430 nm. High entrapment efficiency was obtained ranging from 61.94 to 90.38% with negatively charged zeta potential in the range of -19.1 to -25.7 mV. The release profiles of all formulations exhibited sustained release characteristics over 48 h and the release rates increased as the amount of liquid lipid in lipid core increased. Finally, Precirol NLC with 50% Miglyol® 812 and its corresponding SLN were incorporated in hydrogels. The gels showed adequate pH, non-Newtonian flow with shear-thinning behavior and controlled release profiles. The biological evaluation revealed that MLX-loaded NLC gel showed more pronounced effect compared to MLX-loaded SLN gel. It can be concluded that lipid nanoparticles represent promising particulate carriers for topical application.

  20. 40 CFR 600.007 - Vehicle acceptability.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... a different maximum value for electric vehicles, plug-in hybrid electric vehicles, and fuel cell... 600.007 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) ENERGY POLICY FUEL... Administrator will judge the acceptability of a fuel economy data vehicle on the basis of the information...

  1. 40 CFR 600.007 - Vehicle acceptability.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... a different maximum value for electric vehicles, plug-in hybrid electric vehicles, and fuel cell... 600.007 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) ENERGY POLICY FUEL... Administrator will judge the acceptability of a fuel economy data vehicle on the basis of the information...

  2. 40 CFR 600.007 - Vehicle acceptability.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... a different maximum value for electric vehicles, plug-in hybrid electric vehicles, and fuel cell... 600.007 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) ENERGY POLICY FUEL... Administrator will judge the acceptability of a fuel economy data vehicle on the basis of the information...

  3. Enclomiphene citrate stimulates testosterone production while preventing oligospermia: a randomized phase II clinical trial comparing topical testosterone.

    PubMed

    Wiehle, Ronald D; Fontenot, Gregory K; Wike, Jenny; Hsu, Kuang; Nydell, Jennifer; Lipshultz, Larry

    2014-09-01

    To determine the effect of enclomiphene citrate in men with secondary hypogonadism. Phase II clinical trial. Community dwelling men making visits to physician offices. Men with secondary hypogonadism. Oral administration of enclomiphene citrate or 1% topical T gel. Luteinizing hormone, FSH, T, and semen analysis. Treatment with enclomiphene citrate resulted in increased morning serum T, E2, and LH levels similar to those obtained with a topical T gel in men with secondary hypogonadism. Follicle-stimulating hormone and LH were increased with enclomiphene, and sperm counts were conserved. Enclomiphene citrate reverses the two hallmarks of secondary hypogonadism, namely, low serum total T and low or inappropriately normal LH while preserving sperm production. NCT01270841 (ClinicalTrials.gov Identifier NCT01270841). Copyright © 2014 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

  4. The effect of topical diclofenac 3% and calcitriol 3 μg/g on superficial basal cell carcinoma (sBCC) and nodular basal cell carcinoma (nBCC): A phase II, randomized controlled trial.

    PubMed

    Brinkhuizen, Tjinta; Frencken, Kiki J A; Nelemans, Patty J; Hoff, Marlou L S; Kelleners-Smeets, Nicole W J; Zur Hausen, Axel; van der Horst, Michiel P J; Rennspiess, Dorit; Winnepenninckx, Véronique J L; van Steensel, Maurice A M; Mosterd, Klara

    2016-07-01

    Nonsteroidal anti-inflammatory drugs and vitamin-D derivatives can target signaling pathways activated in basal cell carcinoma (BCC). We investigated the efficacy of topically applied diclofenac sodium 3% gel, calcitriol 3 μg/g ointment, and a combination of both in superficial BCC (sBCC) and nodular BCC. Patients with a primary, histologically proven sBCC (n = 64) or nodular BCC (n = 64) were randomized to topical diclofenac, calcitriol, combination of both, or no topical treatment (control group). After self-application twice daily under occlusion (8 weeks), tumors were excised. Primary outcome was posttreatment expression levels of proliferation (Ki-67) and antiapoptosis (B-cell lymphoma [Bcl-2]) immunohistochemical markers. Secondary outcomes were histologic clearance, adverse events, application-site reactions, and patient compliance. sBCC treated with diclofenac showed a significant decrease in Ki-67 (P < .001) and Bcl-2 (P = .001), and after combination therapy for Ki-67 (P = .012). Complete histologic tumor regression was seen in 64.3% (P = .0003) of sBCC (diclofenac) and 43.8% (P = .007) of sBCC (combination therapy) compared with 0.0% of controls. No significant changes were found in nodular BCC. Application-site reactions were mostly mild to moderate. The sample size was small. Our results suggest that topical diclofenac is a promising new treatment for sBCC. Its mode of action differs from available noninvasive therapies, and thus has an additive value. Copyright © 2016 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.

  5. Topically applied hypericin exhibits skin penetrability on nude mice.

    PubMed

    Li, Zhuo-Heng; Li, Yuan-Yuan; Hou, Min; Yang, Tao; Lu, Lai-Chun; Xu, Xiao-Yu

    2018-06-13

    Hypericin, a powerful natural photosensitizer in photodynamic therapy (PDT), is suitable for treating skin diseases involving excess capillary proliferation. In the present study, we aimed to evaluate the skin penetrability of topically applied hypericin, expecting a reduced risk of prolonged skin photosensitivity, which often occurs after systemic administration. Firstly, the Franz diffusion cell assays were performed to evaluate the penetration effects of different enhancers, including menthol, propylene glycol, camphanone, azone, and carbamide. In view of above evaluation results, we selected menthol as the enhancer in the subsequent in vivo studies. The setting groups were as follows: the blank control group, the light-exposure control group, the gel-base control group, the hypericin gel group, and a hypericin gel-containing menthol group. Except for the blank control, all other animals were irradiated by a LED light. Then, fluorescence microscopy was performed to examine the distribution of hypericin in the skin of nude mouse. Macroscopic and microscopic analyses were also carried out to detect pathological changes in the skin after topical hypericin-PDT treatment. Immunohistochemistry was used to determine the expression change of PECAM-1. As shown in the results, menthol facilitated hypericin penetrate the skin of nude mice most. The results of in vivo assays revealed that hypericin penetrated nude mouse skin, spread to the dermis, and resulted in obvious photosensitivity reaction on the dermal capillaries. Moreover, skin injured by the photosensitive reaction induced by hypericin-PDT treatment was replaced by normal skin within 7 days. We concluded that topical applied hypericin could penetrate nude mouse skin well and has a great potential in PDT treatment of skin diseases.

  6. Phototoxic effects of topical azelaic acid, benzoyl peroxide and adapalene were not detected when applied immediately before UVB to normal skin.

    PubMed

    Cetiner, Salih; Ilknur, Turna; Ozkan, Sebnem

    2004-01-01

    The enhancing effects on UVB erythema of topical agents applied on sun exposed areas are important due to their increased sunburn risk. Since the lesions in acne vulgaris are seen primarily on the face, the effects of topical agents used in acne treatment on the erythemogenicity of UVB is important. The aim of the present study was to examine whether azelaic acid cream, benzoyl peroxide gel, adapalene gel have the enhancing effects on UVB erythema which are widely used in the topical treatment of acne vulgaris. The minimal erythema dose (MED) was determined with phototest in 30 volunteers and the test was repeated with thin (0.1 cc/25 cm(2)) and thick (0.3 cc/25 cm(2)) azelaic acid cream, benzoyl peroxide gel, adapalene gel. The effects of each agent on MED was determined after 24 hours. MEDs of UVB were unaffected by azelaic acid cream, benzoyl peroxide gel and adapalene gel when applied immediately before irradiation. According to our results azelaic acid, benzoyl peroxide and adapalene do not seem to have enhancing effects on UVB erythema and thus increased sunburn risk.

  7. Effects of microcurrent application alone or in combination with topical Hypericum perforatum L. and Arnica montana L. on surgically induced wound healing in Wistar rats.

    PubMed

    Castro, Fabiene C B; Magre, Amanda; Cherpinski, Ricardo; Zelante, Paulo M; Neves, Lia M G; Esquisatto, Marcelo A M; Mendonça, Fernanda A S; Santos, Gláucia M T

    2012-07-01

    This study evaluated the wound healing activity of microcurrent application alone or in combination with topical Hypericum perforatum L. and Arnica montana L. on skin surgical incision surgically induced on the back of Wistar rats. The animals were randomly divided into six groups: (1) no intervention (control group); (2) microcurrent application (10 μA/2 min); (3) topical application of gel containing H. perforatum; (4) topical application of H. perforatum gel and microcurrent (10 μA/2 min); (5) topical application of gel containing A. montana; (6) topical application of A. montana gel and microcurrent (10 μA/2 min). Tissue samples were obtained on the 2nd, 6th and 10th days after injury and submitted to structural and morphometric analysis. Differences in wound healing were observed between treatments when compared to the control group. Microcurrent application alone or combined with H. perforatum gel or A. montana gel exerted significant effects on wound healing in this experimental model in all of the study parameters (P<0.05) when compared to the control group with positive effects seen regarding newly formed tissue, number of newly formed blood vessels and percentage of mature collagen fibers. The morphometric data confirmed the structural findings. In conclusion, application of H. perforatum or A. montana was effective on experimental wound healing when compared to control, but significant differences in the parameters studied were only observed when these treatments were combined with microcurrent application. Copyright © 2012 The Faculty of Homeopathy. Published by Elsevier Ltd. All rights reserved.

  8. In vivo optical imaging of human vaginal gel thickness distributions with a probe-based, dual-modality instrument

    NASA Astrophysics Data System (ADS)

    Drake, Tyler K.; DeSoto, Michael G.; Peters, Jennifer J.; Henderson, Marcus H.; Thiele, Bonnie; Bishop, Tammy Sinclair; Murtha, Amy P.; Katz, David F.; Wax, Adam

    2012-11-01

    We used a probe-based dual-modality optical imaging instrument to measure in vivo coating thickness distributions of a gel distributed along the vaginal lumen, in a clinical study. The gel was a surrogate for one delivering an anti-HIV topical microbicide. Imaging data from Fourier-domain multiplexed low-coherence interferometry (mLCI) and fluorimetric measurements were compared to assess the feasibility and accuracy of mLCI in measuring in vivo gel coating thickness distributions. In each study session, 3.5 mL of Replens gel was inserted to the vaginal fornix while the participant was supine. The participant either: 1. remained supine (10 or 60 min) or 2. sat up (1 min), stood up (1 min), sat down (1 min) and returned to the supine position; net elapsed time was 10 or 60 min after which the gel distribution was imaged. Local coating thickness distributions were qualitatively and quantitatively similar. Here mLCI did not accurately measure thicker gel coatings (>0.8 mm), a limitation not seen with fluorimetry. However, mLCI is capable of measuring in vivo microbicide gel distributions with resolution on the order of 10 μm, without the need for exogenous contrast agents, and can accurately capture relevant summary coating measures in good agreement with fluorimetry.

  9. Topical bioavailability of diclofenac from locally-acting, dermatological formulations.

    PubMed

    Cordery, S F; Pensado, A; Chiu, W S; Shehab, M Z; Bunge, A L; Delgado-Charro, M B; Guy, R H

    2017-08-30

    Assessment of the bioavailability of topically applied drugs designed to act within or beneath the skin is a challenging objective. A number of different, but potentially complementary, techniques are under evaluation. The objective of this work was to evaluate in vitro skin penetration and stratum corneum tape-stripping in vivo as tools with which to measure topical diclofenac bioavailability from three approved and commercialized products (two gels and one solution). Drug uptake into, and its subsequent clearance from, the stratum corneum of human volunteers was used to estimate the input rate of diclofenac into the viable skin layers. This flux was compared to that measured across excised porcine skin in conventional diffusion cells. Both techniques clearly demonstrated (a) the superiority in terms of drug delivery from the solution, and (b) that the two gels performed similarly. There was qualitative and, importantly, quantitative agreement between the in vitro and in vivo measurements of drug flux into and beyond the viable skin. Evidence is therefore presented to support an in vivo - in vitro correlation between methods to assess topical drug bioavailability. The potential value of the stratum corneum tape-stripping technique to quantify drug delivery into (epi)dermal and subcutaneous tissue beneath the barrier is demonstrated. Copyright © 2017 Elsevier B.V. All rights reserved.

  10. OKN-007 decreases free radical levels in a preclinical F98 rat glioma model.

    PubMed

    Coutinho de Souza, Patricia; Smith, Nataliya; Atolagbe, Oluwatomisin; Ziegler, Jadith; Njoku, Charity; Lerner, Megan; Ehrenshaft, Marilyn; Mason, Ronald P; Meek, Bill; Plafker, Scott M; Saunders, Debra; Mamedova, Nadezda; Towner, Rheal A

    2015-10-01

    Free radicals are associated with glioma tumors. Here, we report on the ability of an anticancer nitrone compound, OKN-007 [Oklahoma Nitrone 007; a disulfonyl derivative of α-phenyl-tert-butyl nitrone (PBN)] to decrease free radical levels in F98 rat gliomas using combined molecular magnetic resonance imaging (mMRI) and immunospin-trapping (IST) methodologies. Free radicals are trapped with the spin-trapping agent, 5,5-dimethyl-1-pyrroline N-oxide (DMPO), to form DMPO macromolecule radical adducts, and then further tagged by immunospin trapping by an antibody against DMPO adducts. In this study, we combined mMRI with a biotin-Gd-DTPA-albumin-based contrast agent for signal detection with the specificity of an antibody for DMPO nitrone adducts (anti-DMPO probe), to detect in vivo free radicals in OKN-007-treated rat F98 gliomas. OKN-007 was found to significantly decrease (P < 0.05) free radical levels detected with an anti-DMPO probe in treated animals compared to untreated rats. Immunoelectron microscopy was used with gold-labeled antibiotin to detect the anti-DMPO probe within the plasma membrane of F98 tumor cells from rats administered anti-DMPO in vivo. OKN-007 was also found to decrease nuclear factor erythroid 2-related factor 2, inducible nitric oxide synthase, 3-nitrotyrosine, and malondialdehyde in ex vivo F98 glioma tissues via immunohistochemistry, as well as decrease 3-nitrotyrosine and malondialdehyde adducts in vitro in F98 cells via ELISA. The results indicate that OKN-007 effectively decreases free radicals associated with glioma tumor growth. Furthermore, this method can potentially be applied toward other types of cancers for the in vivo detection of macromolecular free radicals and the assessment of antioxidants. Copyright © 2015. Published by Elsevier Inc.

  11. 46 CFR 159.007-9 - Production inspections and tests.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 46 Shipping 6 2010-10-01 2010-10-01 false Production inspections and tests. 159.007-9 Section 159.007-9 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) EQUIPMENT, CONSTRUCTION, AND MATERIALS: SPECIFICATIONS AND APPROVAL APPROVAL OF EQUIPMENT AND MATERIALS Production Inspection and Tests of Approved Equipment and Materials §...

  12. 46 CFR 159.007-9 - Production inspections and tests.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 46 Shipping 6 2011-10-01 2011-10-01 false Production inspections and tests. 159.007-9 Section 159.007-9 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) EQUIPMENT, CONSTRUCTION, AND MATERIALS: SPECIFICATIONS AND APPROVAL APPROVAL OF EQUIPMENT AND MATERIALS Production Inspection and Tests of Approved Equipment and Materials §...

  13. Development of a non-settling gel formulation of 0.5% loteprednol etabonate for anti-inflammatory use as an ophthalmic drop

    PubMed Central

    Coffey, Martin J; DeCory, Heleen H; Lane, Stephen S

    2013-01-01

    The eye has protective barriers (ie, the conjunctival and corneal membranes) and defense mechanisms (ie, reflex tearing, blinking, lacrimal drainage) which present challenges to topical drug delivery. Topical ocular corticosteroids are commonly used in the treatment of anterior segment diseases and inflammation associated with ocular surgery, and manufacturers continually strive to improve their characteristics. We describe the development of a novel ophthalmic gel formulation of loteprednol etabonate (LE), a C-20 ester-based corticosteroid with an established safety profile, in the treatment of ocular inflammatory conditions. The new LE gel formulation is non-settling, eliminating the need to shake the product to resuspend the drug, has a pH close to that of tears, and a low preservative concentration. The rheological characteristics of LE gel are such that the formulation is instilled as a drop and transitions to a fluid upon instillation in the eye, yet retains sufficient viscosity to prolong ocular surface retention. The new formulation provides consistent, uniform dosing as evidenced by dose extrusion studies, while pharmacokinetic studies in rabbits demonstrated rapid and sustained exposure to LE in ocular tissues following instillation of LE gel. Finally, results from two clinical studies of LE gel in the treatment of postoperative inflammation and pain following cataract surgery indicate that it was safe and effective. Most patients reported no unpleasant drop sensation upon instillation, and reports of blurred vision were rare. PMID:23430378

  14. The effect of theobromine 200 mg/l topical gel exposure duration against surface enamel hardness resistance from 1% citric acid

    NASA Astrophysics Data System (ADS)

    Herisa, H. M.; Noerdin, A.; Eriwati, Y. K.

    2017-08-01

    Theobromine can be used to prevent the demineralization of enamel and can stimulate the growth of new enamels. This study analyzes the effect of theobromine’s gel duration exposure on enamel hardness resistance from 1% citric acid. Twenty-eight specimens were divided into three experimental groups; were exposed to theobromine gel 200 mg/l for 16, 48, and 96 minutes; and were then immersed in 1% citric acid. The control group was only immersed in 1% citric acid. Results: A Wilcoxon test showed a significant increase and decrease in enamel microhardness after exposure to theobromine gel and citric acid (p < 0.05). A Mann-Whitney test showed a significant increase and decrease in enamel microhardness between different durations of exposure to theobromine gel and immersion in citric acid (p < 0.05). The application of theobromine gel 200mg/L increased enamel microhardness but did not contribute to the enamel’s hardness resistance after immersion in 1% citric acid. The duration of theobromine gel application affected enamel microhardness and acid resistance.

  15. In vitro activity of an aqueous allicin extract and a novel allicin topical gel formulation against Lancefield group B streptococci.

    PubMed

    Cutler, Ronald R; Odent, Michel; Hajj-Ahmad, Hussein; Maharjan, Sunil; Bennett, Norman J; Josling, Peter D; Ball, Vanessa; Hatton, Paulette; Dall'Antonia, Martino

    2009-01-01

    Studies have shown the efficacy of intra-partum antibiotics in preventing early-onset group B streptococcal sepsis. This approach results in a high intra-partum antibiotic use. Worryingly, the same antibiotics used in prophylaxis are also first-line treatment for neonatal sepsis, and antibiotic exposure in the peri-natal period has been shown to be a risk factor for late-onset serious bacterial infections and allergic disease. Antibiotic exposure in the peri-natal period is becoming a major public health issue; alternative strategies are needed. Garlic has been traditionally used to treat vaginal infections. Allicin is the main antibacterial agent isolated from garlic. The aim of the study was to investigate the in vitro activity of a novel allicin extract in aqueous and gel formulation against 76 clinical isolates of Lancefield group B streptococci (GBS). MICs and MBCs of allicin were determined for 76 GBS isolates by agar dilution and microtitre plate methods. Killing kinetics were determined for a selected 16 of the 76 strains. Agar diffusion tests were compared for allicin liquid and gel (500 mg/L). MICs and MBCs of allicin liquid were 35 to 95 mg/L and 75 to 315 mg/L, respectively. Time/dose kill curves produced a 2-3 log reduction in cfu/mL within 3 h and no detectable growth at 8 and 24 h. A novel 500 mg/L allicin gel produced an average zone size of 23+/-6 mm compared with 21+/-6 mm for allicin in water. Aqueous allicin is bactericidal against GBS isolates and maintains activity in a novel gel formulation.

  16. Comparison of the cumulative irritation potential of adapalene gel and cream with that of erythromycin/tretinoin solution and gel and erythromycin/isotretinoin gel.

    PubMed

    Queille-Roussel, C; Poncet, M; Mesaros, S; Clucas, A; Baker, M; Soloff, A M

    2001-02-01

    Adapalene is a naphthoic acid derivative with retinoid activity that is effective in the treatment of mild to moderate acne vulgaris. This study assessed the cumulative irritation potential of adapalene gel (0.1%) and adapalene cream (0.1%) compared with that of erythromycin (4%)/tretinoin (0.025%) solution, erythromycin (4%)/tretinoin (0.025%) gel, erythromycin (2%)/isotretinoin (0.05%) gel, and white petrolatum (negative control). This was a single-center, randomized, controlled, investigator-blinded, intraindividual comparison study in healthy subjects with normal skin. The cumulative irritation assay (patch test) was used to assess the potential for irritation (including erythema) of the treatments. Each subject received all study treatments, randomly applied under occlusion (patch), to sites on either side of the midline on the mid-thoracic area of the back. All patches were applied to the same sites throughout the study, unless the degree of reaction to the treatment or adhesive necessitated removal. For 3 weeks, each test material was applied daily, Monday through Friday, for approximately 24 hours; the Friday patches were left in place over the weekend for approximately 72 hours. All 36 subjects (26 men, 10 women; age, 18-49 years [mean, 30 years]) completed the study. In the course of the study, all subjects had > or =1 application discontinued prematurely on > or =1 site due to intolerance. There were no discontinuations with white petrolatum. All erythromycin/tretinoin gel patches were discontinued at day 10; 35 of 36 erythromycin/isotretinoin gel patches were discontinued at day 9; and 35 of 36 erythromycin/tretinoin solution patches were discontinued at day 11 or day 17. The adapalene products, although slightly more irritating (mean cumulative irritation index, 0.25-1) than white petrolatum, were significantly less irritating than the erythromycin/tretinoin and erythromycin/isotretinoin products (P < 0.01). Adapalene gel and cream were well tolerated

  17. The Role of Naftifine HCl 2% Gel and Cream in Treating Moccasin Tinea Pedis.

    PubMed

    Vlahovic, Tracey C

    2016-02-01

    In recent years, new topical antifungals have emerged for the treatment and management of tinea pedis, but all have been investigated and approved for the treatment of interdigital tinea pedis. Moccasin tinea pedis has not been recognized by governing bodies as a definable and treatable disease entity separate from interdigital tinea pedis at this time. Thus, creating randomized, controlled clinical trials to investigate moccasin tinea pedis is a challenge without an agreed upon definition of the disease state, treatment regimen, and treatment course. Considering systemic therapy issues and the lack of data from large trials demonstrating safety and efficacy in the topical management of this clinical presentation, an unmet need has been created for a topical antifungal agent that can treat moccasin tinea pedis. Naftifine 2% gel, an allylamine, was studied in a clinical trial that enrolled patients who had interdigital or both interdigital and moccasin-type tinea pedis. In the moccasin group, the primary efficacy endpoint of complete cure at week 2 (end of treatment) was 1.7% (gel) vs 0.9% (vehicle) and week 6 (four weeks post-treatment) was 19.2% (gel) vs 0.9% (vehicle). Naftifine 2% cream in combination with urea 39% also showed improvement in hyperkeratotic moccasin tinea pedis.

  18. Improved scar appearance with combined use of silicone gel and vitamin C for Asian patients: a comparative case series.

    PubMed

    Yun, In Sik; Yoo, Han-Su; Kim, Yong Oock; Rah, Dong Kyun

    2013-12-01

    In Asians, facial scars, even fine surgical scars, often can be conspicuous and uncomfortable. The authors used a topical silicone gel containing vitamin C on facial scars for the purpose of making the scar less distinct. The study enrolled 80 patients. For the experimental group, the topical silicone gel mixture containing vitamin C was applied from the time of stitch removal to 6 months after the operation. The control group did not undergo any adjunctive treatment. Each participant was evaluated using the modified Vancouver Scar Scale (VSS) as well as erythema and melanin indices by spectrophotometer. With the modified VSS, the experimental group showed a significant decrease in scar elevation (p = 0.026) and erythema (p = 0.025). The hypo- or hyperpigmentation of the scars was more normalized in the experimental group. In the measured results via spectrophotometer, the experimental group showed a significant decrease in the melanin index (p = 0.045). The erythema index showed a statistically significant difference between the time of stitch removal and 6 months after the operation in the experiment group only. Topical use of silicone gel containing vitamin C has the effect of improving the appearance of fine surgical scars in Asian facial skin. This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

  19. Prevention. Part 7: professionally applied topical fluorides for caries prevention.

    PubMed

    Hawkins, R; Locker, D; Noble, J; Kay, E J

    2003-09-27

    This paper reviews the use of professionally applied topical fluorides (PATF) in caries prevention. PATFs are indicated for children and adults with one or more decayed smooth surfaces and/or those who are at high caries risk. Frequency of administration depends on the patient's caries risk, and is usually every 6 months. The effectiveness of fluoride varnish and gel applications has been well established in caries prevention trials involving permanent teeth. Although both types are effective, varnish may be preferred because it is easier to apply, reduces the risk of fluoride over-ingestion, and has greater patient acceptance. Fluoride foams are similar products to gels, but have not been tested clinically. The use of in-office two-part rinses is not recommended because they have not been proven effective. A cleaning, or prophylaxis, is not necessary before the application of topical fluoride for caries prevention. In conclusion, when used appropriately, PATFs are a safe, effective means of reducing caries risk among high-risk populations.

  20. A combined analysis of 2 randomized clinical studies of tretinoin gel 0.05% for the treatment of acne.

    PubMed

    Webster, Guy; Cargill, D Innes; Quiring, John; Vogelson, Cullen T; Slade, Herbert B

    2009-03-01

    Acne vulgaris is a widely prevalent skin disorder primarily treated with retinoids, which have been shown to cause skin irritation. This report describes the combined analysis of 2 similar phase 3 studies designed to evaluate the efficacy and safety of an aqueous gel formulation of tretinoin relative to its vehicle (both studies) and a marketed microsphere formulation of tretinoin (one study) for once-daily topical treatment of acne. Randomized participants 10 years and older with mild to moderate acne (N=1537) received tretinoin gel 0.05% (n=674), tretinoin gel microsphere 0.1% (n=376), or vehicle (n=487) once daily for 12 weeks. Tretinoin gel was more effective than vehicle in reducing inflammatory (P<.001) and noninflammatory (P<.001) lesion counts over 12 weeks. Treatment success rate (global severity score, 0 or 1) was significantly greater in the tretinoin gel 0.05% group compared with the vehicle group (P<.001). The efficacy rate of tretinoin gel 0.05% was approximately 12% less than tretinoin gel microsphere 0.1%. Adverse events (AEs) were generally mild to moderate and rarely resulted in participant discontinuation. Incidence of skin-related AEs in the tretinoin gel 0.05% group (31%) was significantly lower compared with the tretinoin gel microsphere 0.1% group (52%)(P<.001). Thus, tretinoin gel 0.05% applied once daily is a well-tolerated and effective therapy for acne vulgaris and is associated with a low incidence of skin-related AEs.

  1. Release of a wound-healing agent from PLGA microspheres in a thermosensitive gel.

    PubMed

    Machado, H A; Abercrombie, J J; You, T; Deluca, P P; Leung, K P

    2013-01-01

    The purpose of this research was to develop a topical microsphere delivery system in a thermosensitive 20% poloxamer 407 gel (Pluronic F127) to control release of KSL-W, a cationic antimicrobial decapeptide, for a period of 4-7 days for potential application in combat related injuries. KSL-W loaded microsphere formulations were prepared by a solvent extraction-evaporation method (water-oil-water), with poly (D,L-lactic-co-glycolic acid) (PLGA) (50 : 50, low-weight, and hydrophilic end) as the polymeric system. After optimization of the process, three formulations (A, B, and C) were prepared with different organic to water ratio of the primary emulsion while maintaining other components and manufacturing parameters constant. Formulations were characterized for surface morphology, porous nature, drug loading, in vitro drug release, and antimicrobial activity. Microspheres containing 20% peptide with porous surfaces and internal structure were prepared in satisfactory yields and in sizes varying from 25 to 50 μm. Gels of 20% Pluronic F127, which were liquid at or below 24.6°C and formed transparent films at body temperature, were used as carriers for the microspheres. Rheological studies showed a gelation temperature of 24.6°C for the 20% Pluronic F127 gel alone. Gelation temperature and viscosity of formulations A, B, and C as a function of temperature were very close to those of the carrier. A Franz diffusion cell system was used to study the release of peptide from the microspheres suspended in both, phosphate-buffered saline (PBS) and a 20% Pluronic F127 gel. In vitro release of greater than 50% peptide was found in all formulations in both PBS and the gel, and in one formulation there was a release of 75% in both PBS and the gel. Fractions collected from the release process were also tested for bactericidal activity against Staphylococcus epidermidis using the broth microdilution method and found to provide effective antimicrobial activity to warrant

  2. A combined approach of enamel matrix derivative gel and autogenous bone grafts in treatment of intrabony periodontal defects. A case report.

    PubMed

    Leung, George; Jin, Lijian

    2003-04-01

    Enamel matrix derivative (EMD) has recently been introduced as a new modality in regenerative periodontal therapy. This case report demonstrates a combined approach in topical application of EMD gel (Emdogain) and autogenous bone grafts for treatment of intrabony defects and furcation involvement defects in a patient with chronic periodontitis. The seven-month post-surgery clinical and radiographic results were presented. The combined application of EMD gel with autogenous bone grafts in intrabony osseous defects resulted in clinically significant gain of attachment on diseased root surfaces and bone fill on radiographs. Further controlled clinical studies are required to confirm the long-term effectiveness of the combination of EMD gel and autogenous bone grafts in treatment of various osseous defects in subjects with chronic periodontitis.

  3. The Effects of NBF Gingival Gel Application in the Treatment of the Erosive Lichen Planus: Case Report.

    PubMed

    Popovska, Mirjana; Fidovski, Jasmin; Mindova, Sonja; Dirjanska, Katerina; Ristoska, Stevica; Stefanovska, Emilija; Radojkova-Nikolovska, Vera; Mitic, Kristina; Rusevska, Biljana

    2016-03-15

    The therapy of erosive lichen planus (ELP) has been particular problem in the treatment of oral lesions. This case of ELP in male patient 29 years old was treated with topic application of the NBF gingival gel, three times a day after meal, previously rinsed with Clorhexidine gluconate 0.12%. After 5 days of treatment, initial improvements were recorded, and after two weeks of application of the NBF gingival gel we observed significant improvement. Clinical monitoring after the fifth day showed mild epithelialization of the eroded mucosa, yet still present erythematous base of the lesion. After the second week the erythema area was significantly reduced and the eroded surfaces of the mucosa were minimal, measured less than 0.5 mm. After the third week there were no erosions to detect on the oral mucosa, yet still present vague redness, which completely pulled after the fourth week. Treatment ended after the fifth week when the topical application of the NBF gingival gel was terminated, and therapy was done, and clinically achieved effects remained stable even after the third month of the treatment. Topic application of the NBF gingival gel with ELP patients showed positive clinical effects in relatively short time period.

  4. The Effects of NBF Gingival Gel Application in the Treatment of the Erosive Lichen Planus: Case Report

    PubMed Central

    Popovska, Mirjana; Fidovski, Jasmin; Mindova, Sonja; Dirjanska, Katerina; Ristoska, Stevica; Stefanovska, Emilija; Radojkova-Nikolovska, Vera; Mitic, Kristina; Rusevska, Biljana

    2016-01-01

    The therapy of erosive lichen planus (ELP) has been particular problem in the treatment of oral lesions. This case of ELP in male patient 29 years old was treated with topic application of the NBF gingival gel, three times a day after meal, previously rinsed with Clorhexidine gluconate 0.12%. After 5 days of treatment, initial improvements were recorded, and after two weeks of application of the NBF gingival gel we observed significant improvement. Clinical monitoring after the fifth day showed mild epithelialization of the eroded mucosa, yet still present erythematous base of the lesion. After the second week the erythema area was significantly reduced and the eroded surfaces of the mucosa were minimal, measured less than 0.5 mm. After the third week there were no erosions to detect on the oral mucosa, yet still present vague redness, which completely pulled after the fourth week. Treatment ended after the fifth week when the topical application of the NBF gingival gel was terminated, and therapy was done, and clinically achieved effects remained stable even after the third month of the treatment. Topic application of the NBF gingival gel with ELP patients showed positive clinical effects in relatively short time period. PMID:27275352

  5. Internal structure analysis of particle-double network gels used in a gel organ replica

    NASA Astrophysics Data System (ADS)

    Abe, Mei; Arai, Masanori; Saito, Azusa; Sakai, Kazuyuki; Kawakami, Masaru; Furukawa, Hidemitsu

    2016-04-01

    In recent years, the fabrication of patient organ replicas using 3D printers has been attracting a great deal of attention in medical fields. However, the cost of these organ replicas is very high as it is necessary to employ very expensive 3D printers and printing materials. Here we present a new gel organ replica, of human kidney, fabricated with a conventional molding technique, using a particle-double network hydrogel (P-DN gel). The replica is transparent and has the feel of a real kidney. It is expected that gel organ replicas produced this way will be a useful tool for the education of trainee surgeons and clinical ultrasonography technologists. In addition to developing a gel organ replica, the internal structure of the P-DN gel used is also discussed. Because the P-DN gel has a complex structure comprised of two different types of network, it has not been possible to investigate them internally in detail. Gels have an inhomogeneous network structure. If it is able to get a more uniform structure, it is considered that this would lead to higher strength in the gel. In the present study we investigate the structure of P-DN gel, using the gel organ replica. We investigated the internal structure of P-DN gel using Scanning Microscopic Light Scattering (SMILS), a non-contacting and non-destructive.

  6. sts093-s-007

    NASA Image and Video Library

    2009-09-23

    STS93-S-007 (23 July 1999) --- Framed by Florida foliage in this night time scene, the Space Shuttle Columbia lifts off from Launch Pad 39B to begin the five-day STS-93 mission. After two unsuccessful attempts earlier in the week, liftoff occurred at 12:31 a.m. (EDT), July 23, 1999. Only hours after this picture was taken, the five-member crew released the Chandra X-Ray Observatory into orbit. Onboard were astronauts Eileen M. Collins, first woman shuttle commander; Jeffrey S. Ashby, pilot; and Steven A. Hawley, Catherine G. Coleman and Michel Tognini, all mission specialists. Tognini represents the Centre National d'Etudes Spatiales (CNES) of France.

  7. Topical Ketoprofen Versus Placebo in Treatment of Acute Ankle Sprain in the Emergency Department.

    PubMed

    Serinken, Mustafa; Eken, Cenker; Elicabuk, Hayri

    2016-09-01

    Topical agents have been shown to be effective in soft tissue injuries and commonly used in outpatient clinics. However, the data regarding topical agents in the emergency department is insufficient, and they are not used often in the emergency department setting. The present study aimed to compare the effect of 2.5% topical ketoprofen (gel form) to placebo in patients presenting with ankle sprain to the emergency department. Patients presenting with ankle sprain composed the study population. Study patients were randomized into 2 study arms: 2.5% ketoprofen gel and placebo administered over a 5-cm area locally. Pain alleviation was measured by visual analog scale at 15 and 30 minutes. A total of 100 patients were included in the final analysis. The median pain reduction in ketoprofen and placebo groups at 15 minutes was 27 (19.8-33.4) and 9 (7.6-17), respectively. The median pain reduction at 30 minutes for both groups was 42 (36-50.8) and 20 (17.6-24.4), respectively. Pain improvement either at 15 minutes (median difference: 16 [9-22]) or 30 minutes (median difference: 21 [15-27]) was better in the ketoprofen group than placebo. There were no adverse effects in either group. Ketoprofen gel was superior to placebo at 30 minutes in alleviating pain secondary to ankle sprain in the ED with a high safety profile. Further studies are needed concerning the effect of ketoprofen gel for long-term effects. Level I, high quality prospective randomized study. © The Author(s) 2016.

  8. Coating flow of an anti-HIV microbicide gel: boundary dilution and yield stress

    NASA Astrophysics Data System (ADS)

    Szeri, Andrew J.; Tasoglu, Savas; Park, Su Chan; Katz, David F.

    2010-11-01

    A recent study has confirmed, for the first time, that a vaginal gel formulation of the antiretroviral drug Tenofovir, when topically applied, significantly inhibits sexual HIV transmission to women [1]. However, the gel for this drug, and anti-HIV microbicide gels in general, have not been designed using an understanding of how gel spreading govern successful drug delivery. Elastohydrodynamic lubrication theory can be applied to model spreading of microbicide gels [2]. Here, we extend our initial analysis: we incorporate a yield stress, and we model the effects of gel dilution due to contact with vaginal fluid produced at the gel-tissue interface. Our model developed in [2] is supplemented with a convective-diffusive transport equation to characterize dilution, and solved using a multi-step scheme in a moving domain. The association between local dilution of gel and rheological properties is obtained experimentally. To model the common yield stress property of gels, we proceed by scaling analysis first. This establishes the conditions for validity of lubrication theory of a shear thinning yield stress fluid. This involves further development of the model in [2], incorporating a biviscosity model.[4pt] [1] Karim, et al., Science, 2010.[0pt] [2] Szeri, et al., Phy. of Fluids, 2008.

  9. Azelaic acid 15% gel: in the treatment of papulopustular rosacea.

    PubMed

    Frampton, James E; Wagstaff, Antona J

    2004-01-01

    Azelaic acid is a naturally occurring, straight-chain dicarboxylic acid which is effective in the treatment of rosacea, presumably on account of its anti-inflammatory properties. In randomized, double-blind, multicenter studies involving patients with moderate papulopustular facial rosacea, twice-daily topical application of azelaic acid 15% gel to the face was significantly more effective than twice-daily administration of either its vehicle (two studies) or metronidazole 0.75% gel (one study) in reducing inflammatory lesion counts and erythema severity. However, neither active treatment had a clinically discernable effect on telangiectasia. In all three studies, azelaic acid 15% gel recipients experienced continuous decreases in lesion counts and erythema throughout the 12- to 15-week treatment periods. However, the effects of metronidazole 0.75% gel plateauxed after 8 weeks. In other efficacy assessments in these studies, azelaic acid 15% gel was superior to its vehicle and metronidazole 0.75% gel in both the investigators' global assessment of rosacea and the investigators' end-of-study evaluation of overall improvement, and superior to its vehicle in the patients' end-of-study evaluation of overall improvement. The most frequent treatment-related cutaneous adverse events during administration of azelaic acid 15% gel include burning/stinging/tingling and pruritus (itching); however, these events are predominantly transient in nature and mild-to-moderate in intensity.

  10. Topical anesthesia for rubber dam clamp placement in sealant placement: comparison of lidocaine/prilocaine gel and benzocaine.

    PubMed

    Yoon, Richard K; Chussid, Steven

    2009-01-01

    The purpose of this prospective study was to compare the efficacy of Oraqix to benzocaine while placing a rubber dam clamp during sealant placement on children. A sample size of 45 7- to 12-year-old patients who presented for bilateral sealants on permanent first molars participated in this study. A split-mouth design was implemented with Oraqix applied to one side and 20 percent benzocaine gel applied to the other. After placing the topical anesthetic and the rubber dam clamp, patients completed a Feces Pain Scale (FPS) to rate the level of discomfort after clamp placement. Twenty-seven subjects (60%) were female and 18 subjects (40%) were mole; 15 (33%) were younger than 9 years old and 30 (67%) were at least 9 years old. The overall difference in mean FPS ratings was not statistically significant (P = .27). Regarding gender, there was no statistically significant difference in males (P = .65) or females (P = .26). There was also no difference in mean FPS ratings when looking at age groups younger than 9 years old with P=.77 In the 9 years and older age groups, however there was a statistically significant difference, with P = .04. Application of Oraqix did not reduce discomfort when compared to benzocaine in this small sample size. Oraqix was more effective than benzocaine in the age group 9 and older. A larger sample size is needed to determine its efficacy in children younger than 9years old.

  11. Azelaic Acid Topical Formulations: Differentiation of 15% Gel and 15% Foam.

    PubMed

    Del Rosso, James Q

    2017-03-01

    In this article, the author reviews topical formulations of azelaic acid used to treat papulopustular rosacea. Emphasis is placed on differences in vehicle technology and potential clinical impact of the possibility for neurosensory cutaneous tolerability reactions.

  12. Evaluation of radiochromic gel dosimetry and polymer gel dosimetry in a clinical dose verification

    NASA Astrophysics Data System (ADS)

    Vandecasteele, Jan; De Deene, Yves

    2013-09-01

    A quantitative comparison of two full three-dimensional (3D) gel dosimetry techniques was assessed in a clinical setting: radiochromic gel dosimetry with an in-house developed optical laser CT scanner and polymer gel dosimetry with magnetic resonance imaging (MRI). To benchmark both gel dosimeters, they were exposed to a 6 MV photon beam and the depth dose was compared against a diamond detector measurement that served as golden standard. Both gel dosimeters were found accurate within 4% accuracy. In the 3D dose matrix of the radiochromic gel, hotspot dose deviations up to 8% were observed which are attributed to the fabrication procedure. The polymer gel readout was shown to be sensitive to B0 field and B1 field non-uniformities as well as temperature variations during scanning. The performance of the two gel dosimeters was also evaluated for a brain tumour IMRT treatment. Both gel measured dose distributions were compared against treatment planning system predicted dose maps which were validated independently with ion chamber measurements and portal dosimetry. In the radiochromic gel measurement, two sources of deviations could be identified. Firstly, the dose in a cluster of voxels near the edge of the phantom deviated from the planned dose. Secondly, the presence of dose hotspots in the order of 10% related to inhomogeneities in the gel limit the clinical acceptance of this dosimetry technique. Based on the results of the micelle gel dosimeter prototype presented here, chemical optimization will be subject of future work. Polymer gel dosimetry is capable of measuring the absolute dose in the whole 3D volume within 5% accuracy. A temperature stabilization technique is incorporated to increase the accuracy during short measurements, however keeping the temperature stable during long measurement times in both calibration phantoms and the volumetric phantom is more challenging. The sensitivity of MRI readout to minimal temperature fluctuations is demonstrated which

  13. 48 CFR 432.007 - Contract financing payments.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 48 Federal Acquisition Regulations System 4 2010-10-01 2010-10-01 false Contract financing... CONTRACTING REQUIREMENTS CONTRACT FINANCING 432.007 Contract financing payments. The HCA may prescribe, on a case-by-case basis, a shorter period for financing payments. [61 FR 53646, Oct. 15, 1996. Redesignated...

  14. Application of melanin-free ink as a new antioxidative gel enhancer in sardine surimi gel.

    PubMed

    Vate, Naveen Kumar; Benjakul, Soottawat; Agustini, Tri Winarni

    2015-08-30

    The squid ink that is discarded as waste during processing can be effectively utilised as a gel enhancer in surimi gels, especially those prepared from dark-fleshed fish which have poor gel properties. It also acts as an antioxidant, inhibiting lipid oxidation. This investigation aimed to study the effect of melanin-free ink (MFI) from splendid squid (Loligo formosana) on properties and oxidative stability of surimi gel from sardine (Sardinella albella). MFI (0-0.1 g kg(-1) surimi) increased the breaking force and deformation of sardine surimi gel in a dose-dependent manner (P < 0.05). The addition of MFI had no effect on whiteness of surimi gels (P > 0.05). The expressible moisture content of gels decreased as the levels of MFI increased (P < 0.05). Based on a microstructure study, gel added with MFI at a level of 0.08 g kg(-1) surimi was denser and finer than that of the control (without MFI). Surimi gels with MFI had lower peroxide values, thiobarbituric acid reactive substances, nonanal and 2-decenal. MFI could improve the properties of sardine surimi gel. Additionally, it was able to prevent lipid oxidation in surimi gels during refrigerated storage. © 2014 Society of Chemical Industry.

  15. 48 CFR 232.007 - Contract financing payments.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 48 Federal Acquisition Regulations System 3 2010-10-01 2010-10-01 false Contract financing... SYSTEM, DEPARTMENT OF DEFENSE GENERAL CONTRACTING REQUIREMENTS CONTRACT FINANCING 232.007 Contract financing payments. (a) DoD policy is to make contract financing payments as quickly as possible. Generally...

  16. 46 CFR 159.007-13 - Production inspections and tests: Records.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 46 Shipping 6 2011-10-01 2011-10-01 false Production inspections and tests: Records. 159.007-13 Section 159.007-13 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) EQUIPMENT, CONSTRUCTION, AND MATERIALS: SPECIFICATIONS AND APPROVAL APPROVAL OF EQUIPMENT AND MATERIALS Production Inspection and Tests of Approved Equipment and...

  17. 46 CFR 159.007-13 - Production inspections and tests: Records.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 46 Shipping 6 2010-10-01 2010-10-01 false Production inspections and tests: Records. 159.007-13 Section 159.007-13 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) EQUIPMENT, CONSTRUCTION, AND MATERIALS: SPECIFICATIONS AND APPROVAL APPROVAL OF EQUIPMENT AND MATERIALS Production Inspection and Tests of Approved Equipment and...

  18. Acceptability of a transdermal gel-based male hormonal contraceptive in a randomized controlled trial.

    PubMed

    Roth, Mara Y; Shih, Grace; Ilani, Niloufar; Wang, Christina; Page, Stephanie T; Bremner, William J; Swerdloff, Ronald S; Sitruk-Ware, Regine; Blithe, Diana L; Amory, John K

    2014-10-01

    Fifty percent of pregnancies in the United States are unintended despite numerous contraceptive methods available to women. The only male contraceptive methods, vasectomy and condoms, are used by 10% and 16% of couples, respectively. Prior studies have shown efficacy of male hormonal contraceptives in development, but few have evaluated patient acceptability and potential use if commercially available. The objective of this study is to determine if a transdermal gel-based male hormonal contraceptive regimen, containing testosterone and Nestorone® gels, would be acceptable to study participants as a primary contraceptive method. As part of a three-arm, 6-month, double-blind, randomized controlled trial of testosterone and nestorone gels at two academic medical centers, subjects completed a questionnaire to assess the acceptability of the regimen. Of the 99 men randomized, 79 provided data for analysis. Overall, 56% (44/79) of men were satisfied or extremely satisfied with this gel-based method of contraception, and 51% (40/79) reported that they would recommend this method to others. One third of subjects (26/79) reported that they would use this as their primary method of contraception if it were commercially available today. However, men with concerns about sexually transmitted disease were significantly less satisfied than men without such concerns (p=0.03). A majority of the men who volunteered to participate in this trial of an experimental male hormonal contraceptive were satisfied with this transdermal male hormonal contraceptive. If commercially available, a combination of topical nesterone and testosterone gels could provide a reversible, effective method of contraception that is appealing to men. A substantial portion of men report they would use this transdermal male contraceptive regimen if commercially available. This method would provide a novel, reversible method of contraception for men, whose current choices are limited to condoms and vasectomy

  19. Fingolimod hydrochloride gel shows promising therapeutic effects in a mouse model of atopic dermatitis.

    PubMed

    Tamakuwala, Mayurkumar; Ratna, Warren; Joshi, Amit; Stagni, Grazia

    2016-10-01

    To assess the efficacy of topically applied 2% hydroxypropyl cellulose gels containing 0.5% fingolimod hydrochloride (FNGL) with or without 6% colloidal oatmeal in an in vivo model of atopic dermatitis (AD). AD-like lesions were induced in SKH1/Hr hairless mice and were treated with FNGL gels, non-medicated base gels and Elidel(®) cream for 6 weeks. The severity/improvement of the lesions was assessed regularly using the Eczema Area and Severity Index (EASI), pH of the skin, transepidermal water loss, g/m(2) /h (TEWL), humidity and temperature. At the end of the experiments, the plasma levels of cytokines, FNGL and white blood cells were determined. The EASI score was almost unchanged for the vehicle-only groups compared to before the treatments, whereas the medicated groups showed a significant decrease in the overall EASI score (P < 0.01), although there was non-significant differences among them (P > 0.081). Both the FNGL groups also showed a significant (P ˂ 0.05) reduction in blood WBC. This study shows that the gels containing 0.50% FNGL and FNGL 0.50% plus 6% colloidal oatmeal have potential for the treatment of AD. The presence of colloidal oatmeal may provide additional benefits. © 2016 Royal Pharmaceutical Society.

  20. Efficacy and safety of azelaic acid (AzA) gel 15% in the treatment of post-inflammatory hyperpigmentation and acne: a 16-week, baseline-controlled study.

    PubMed

    Kircik, Leon H

    2011-06-01

    Although there are few differences in the incidence and pathophysiology of acne across various races and ethnicities, there is some evidence that black patients may have larger sebaceous glands and increased sebum production. Of greater clinical relevance, patients with darker skin types are at increased risk for the development of post-inflammatory hyperpigmentation (PIH), which some find as or more troubling than acne itself. This common and bothersome sequelum of acne can be difficult to manage in this population. Topical azelaic acid gel is recognized to have anti-tyrosinase activity, suggesting it may be a suitable treatment option for mild-to-moderate acne with associated moderate-to-severe PIH. This pilot study demonstrates the efficacy of topical AzA gel 15% when applied twice daily for the reduction of both acne and PIH. J

  1. Assessment of Anti HSV-1 Activity of Aloe Vera Gel Extract: an In Vitro Study

    PubMed Central

    Rezazadeh, Fahimeh; Moshaverinia, Maryam; Motamedifar, Mohammad; Alyaseri, Montazer

    2016-01-01

    Statement of the Problem Herpes simplex virus (HSV) infection is one of the most common and debilitating oral diseases; yet, there is no standard topical treatment to control it. The extract of Aloe vera leaves has been previously reported to have anti-inflammatory, antibacterial, and also antiviral effects. There is no data on anti-Herpes simplex virus type 1 (HSV-1) activity of Aloe vera gel. Purpose This study aimed to evaluate the anti-HSV-1 activity of Aloe vera gel in Vero cell line. Materials and Method In this study, gel extraction and cytotoxicity of various increasing concentrations of Aloe vera gel (0.2, 0.5, 1, 2, and 5%) was evaluated in Dulbecco’s Modified Eagle Medium (DMEM) containing 2% fetal bovine serum (FBS). Having been washed with phosphate buffered saline, 50 plaque-forming units (PFU) of HSV-1 was added to each well. After 1 hour of incubation at 37°C, cell monolayers in 24 well plates were exposed to different increasing concentrations of Aloe vera gel. The anti-HSV-1 activity of Aloe vera gel in different concentrations was assessed by plaque reduction assays. Data were analyzed by using One-way ANOVA. Results The cytotoxicity assay showed that Aloe vera in prearranged concentrations was cell-compatible. The inhibitory effect of various concentrations of Aloe vera was observed one hour after the Vero cell was infected with HSV-1. However, there was no significant difference between two serial concentrations (p> 0.05). One-way ANOVA also revealed no significant difference between the groups. The findings indicated a dose-dependent antiviral effect of Aloe vera. Conclusion The findings showed significant inhibitory effect of 0.2-5% Aloe vera gel on HSV-1 growth in Vero cell line. Therefore, this gel could be a useful topical treatment for oral HSV-1 infections without any significant toxicity. PMID:26966709

  2. Topical NSAIDs for chronic musculoskeletal pain in adults

    PubMed Central

    Derry, Sheena; Moore, R Andrew; Rabbie, Roy

    2014-01-01

    Background Non-steroidal anti-inflammatory drugs (NSAIDs) are commonly taken orally, but they are also available in topical preparations to be applied to or rubbed onto the skin of a painful joint, typically one affected by arthritis, with the aim of relieving pain locally. Topical NSAIDs are widely used in some parts of the world for acute and chronic painful conditions, but have not been universally accepted until recently. One of the problems has been that older clinical studies were generally short, lasting four weeks or less, and short duration studies are not regarded as adequate in ongoing painful conditions. Objectives To examine the use of topical NSAIDs in chronic musculoskeletal pain, focusing on studies of high methodological quality, and examining the measured effect of the preparations according to study duration. The principal aim was to estimate treatment efficacy in longer duration studies of at least 8 weeks. Search methods A series of electronic searches, together with bibliographic searches, and searches of in-house databases were combined with electronic searches of clinical trial registers and manufacturers of topical NSAIDs, or companies known to be actively researching topical NSAIDs. There had to be at least 10 participants in each treatment arm, with application of treatment at least once daily. Selection criteria Randomised, double blind studies with placebo or active comparators, where at least one treatment was a topical NSAID product, in any topical formulation (cream, gel, patch, solution), in studies lasting at least two weeks. Data collection and analysis Two review authors independently assessed study quality and validity, and extracted data. Numbers of participants achieving each outcome were used to calculate relative risk (RR) and numbers needed to treat (NNT) or harm (NNH) compared to placebo or other active treatment. Main results Information was available from 7688 participants in 34 studies from 32 publications; 23 studies

  3. Azelaic Acid Topical Formulations: Differentiation of 15% Gel and 15% Foam

    PubMed Central

    2017-01-01

    In this article, the author reviews topical formulations of azelaic acid used to treat papulopustular rosacea. Emphasis is placed on differences in vehicle technology and potential clinical impact of the possibility for neurosensory cutaneous tolerability reactions. PMID:28360967

  4. Utility of colposcopy in a phase 2 portion of a microbicide clinical trial of BufferGel and 0.5% PRO 2000 Gel

    PubMed Central

    Chirenje, Zvavahera M; Mâsse, Benoît R; Maslankowski, Lisa A; Ramjee, Gita; Coletti, Anne S; Tembo, Tchangani N; Magure, Tsitsi M; Soto-Torres, Lydia; Kelly, Cliff; Hillier, Sharon; Karim, Abdool

    2012-01-01

    Background The majority of new HIV infections are acquired through heterosexual transmission. There is urgent need for prevention methods to compliment behavior change and condom use. Topical microbicide represent a potential strategy for reduction of HIV transmission in women. Methods Monthly Colposcopy evaluations were performed during pelvic examinations among 299 women enrolled in the Phase 2 portion of HPTN 035 study at four sites (1 in USA, 3 in Southern Africa). This was a phase 2/2b, multisite, randomized, and controlled clinical trial with four arms: BufferGel, 0.5% PRO2000 Gel, placebo gel and no gel. At two of the sites, pelvic examinations were conducted by the use of naked eye without colposcopy. Results A colposcopy finding of any kind was detected in 48% of participants at baseline compared to 40% at 3 months (p =0.04). The lower rates were also observed in vaginal discharge (22% at baseline, 16% at 3 months, p=0.06), erythema (15% at baseline, 8% at 3 months, p=0.004). The trend towards significance at p=0.05 disappear when utilizing stringent statistical significance levels. A pelvic finding of any kind was detected in 71% of colposcopy participants compared to 41% of participants who had naked eye examination only conducted at two sites that performed both colposcopy and naked eye without colposcopy. Use of colposcopy yielded significantly higher rates of participants with deep epithelial disruption, erythema and ecchymosis. We observed no cases of incident Chlamydia, Gonorrhea, or Syphilis during the three month follow up. There were 2 cases of incident HIV during 3-month study period neither of which was associated with any abnormal colposcopy evaluation findings. Conclusion No safety signals were observed in the 4 study arms, allowing seamless transition from phase 2 to 2b. Colposcopy utility in microbicide clinical trials has minimal value given high rates of background noise findings of no relevant clinical significance. PMID:22944480

  5. Utility of colposcopy in a phase 2 portion of a microbicide clinical trial of BufferGel and 0.5% PRO 2000 Gel.

    PubMed

    Chirenje, Zvavahera M; Mâsse, Benoît R; Maslankowski, Lisa A; Ramjee, Gita; Coletti, Anne S; Tembo, Tchangani N; Magure, Tsitsi M; Soto-Torres, Lydia; Kelly, Cliff; Hillier, Sharon; Karim, Abdool

    2012-08-27

    The majority of new HIV infections are acquired through heterosexual transmission. There is urgent need for prevention methods to compliment behavior change and condom use. Topical microbicide represent a potential strategy for reduction of HIV transmission in women. Monthly Colposcopy evaluations were performed during pelvic examinations among 299 women enrolled in the Phase 2 portion of HPTN 035 study at four sites (1 in USA, 3 in Southern Africa). This was a phase 2/2b, multisite, randomized, and controlled clinical trial with four arms: BufferGel, 0.5% PRO2000 Gel, placebo gel and no gel. At two of the sites, pelvic examinations were conducted by the use of naked eye without colposcopy. A colposcopy finding of any kind was detected in 48% of participants at baseline compared to 40% at 3 months (p =0.04). The lower rates were also observed in vaginal discharge (22% at baseline, 16% at 3 months, p=0.06), erythema (15% at baseline, 8% at 3 months, p=0.004). The trend towards significance at p=0.05 disappear when utilizing stringent statistical significance levels. A pelvic finding of any kind was detected in 71% of colposcopy participants compared to 41% of participants who had naked eye examination only conducted at two sites that performed both colposcopy and naked eye without colposcopy. Use of colposcopy yielded significantly higher rates of participants with deep epithelial disruption, erythema and ecchymosis. We observed no cases of incident Chlamydia, Gonorrhea, or Syphilis during the three month follow up. There were 2 cases of incident HIV during 3-month study period neither of which was associated with any abnormal colposcopy evaluation findings. No safety signals were observed in the 4 study arms, allowing seamless transition from phase 2 to 2b. Colposcopy utility in microbicide clinical trials has minimal value given high rates of background noise findings of no relevant clinical significance.

  6. 40 CFR 600.007-08 - Vehicle acceptability.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 40 Protection of Environment 30 2011-07-01 2011-07-01 false Vehicle acceptability. 600.007-08... FUEL ECONOMY AND CARBON-RELATED EXHAUST EMISSIONS OF MOTOR VEHICLES Fuel Economy and Carbon-Related... Vehicle acceptability. (a) All certification vehicles and other vehicles tested to meet the requirements...

  7. 40 CFR 600.007-80 - Vehicle acceptability.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 40 Protection of Environment 30 2011-07-01 2011-07-01 false Vehicle acceptability. 600.007-80... FUEL ECONOMY AND CARBON-RELATED EXHAUST EMISSIONS OF MOTOR VEHICLES Fuel Economy and Carbon-Related... Vehicle acceptability. (a) All certification vehicles and other vehicles tested to meet the requirements...

  8. 48 CFR 32.007 - Contract financing payments.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 48 Federal Acquisition Regulations System 1 2011-10-01 2011-10-01 false Contract financing... GENERAL CONTRACTING REQUIREMENTS CONTRACT FINANCING 32.007 Contract financing payments. (a)(1) Unless... section, the due date for making contract financing payments by the designated payment office is the 30th...

  9. WPVS 007: Dramatic Broad Absorption Line Variability in a Narrow-line Seyfert 1

    NASA Astrophysics Data System (ADS)

    Cooper, Erin M.; Leighly, K.; Hamann, F. W.; Grupe, D.; Dietrich, M.

    2014-01-01

    Blue-shifted broad absorption lines are the manifestation of gaseous outflows in astrophysical phenomena. In active galaxies, these outflowing winds may play a key role in the central engine physics by removing angular momentum and in influencing host galaxy evolution by imparting energy and chemically enriched gas to the surrounding medium. AGN wind variability affords us a valuable tool to study this still poorly understood phenomenon. The existence of a high velocity broad line outflow in WPVS007 is especially extraordinary, as Seyfert-luminosity active galaxies are unexpected to produce them. With its lower luminosity and compact size, the NLS1 galaxy WPVS007 (M_V=-19.7, z=0.02882) provides us the ability to study even colossal variability on merely human timescales. Since its 1996 FOS observation, displaying miniBALs but no true broad absorption lines, WPVS007 has experienced a short but rich history of UV BAL variability. By the 2003 FUSE observation, WPVS007 had developed a BAL with v_max ~ 6000km/s, indicating an optically thick, high velocity outflow. We present the 2010 and 2013 June and December HST COS spectra. Between 2003 and 2010, both the maximum and minimum outflow velocity had increased substantially. As of 2013 June, the continuum emission has since dimmed by a factor of ~2 and the BALs have appeared to weaken, with both decreased maximum and minimum velocities. Such dramatic shifts in BAL velocity are unprecedented, as BAL variability is typically confined to changes in optical depth. What is the nature of the variability in this BAL wind? The upcoming (as of the writing of this abstract) December observation should give us more insight into tackling that question, whether it be the transient response of a continuous flow to a fluctuating continuum or perhaps the continued decline of a discrete outflow event.

  10. Preparation, characterization and efficacy of lysostaphin-chitosan gel against Staphylococcus aureus.

    PubMed

    Nithya, Sai; Nimal, T R; Baranwal, Gaurav; Suresh, Maneesha K; C P, Anju; Anil Kumar, V; Gopi Mohan, C; Jayakumar, R; Biswas, Raja

    2018-04-15

    Lysostaphin (LST) is a bacteriocin that cleaves within the pentaglycine cross bridge of Staphylococcus aureus peptidoglycan. Previous studies have reported the high efficiency of LST even against multi drug resistant S. aureus including methicillin resistant S. aureus (MRSA). In this study, we have developed a new chitosan based hydrogel formulation of LST to exploit its anti-staphylococcal activity. The atomic interactions of LST with chitosan were studied by molecular docking studies. The rheology and the antibacterial properties of the developed LSTC gel were evaluated. The developed LST containing chitosan hydrogel (LSTC gel) was flexible, flows smoothly and remains stable at physiological temperature. The in vitro studies by agar well diffusion and ex vivo studies in porcine skin model exhibited a reduction in S. aureus survival by ∼3 Log 10 CFU/mL in the presence of LSTC gel. The cytocompatibility of the gel was tested in vitro using macrophage RAW 264.7 cell line and in vivo in Drosophila melanogaster. A gradual disruption of S. aureus biofilms with the increase of LST concentrations in the LSTC gel was observed which was confirmed by SEM analysis. We conclude that LSTC gel could be highly effectual and advantageous over antibiotics in treating staphylococcal-topical and biofilm infections. Copyright © 2018 Elsevier B.V. All rights reserved.

  11. Isolation and characterization of a proteinaceous antifungal compound from Lactobacillus plantarum YML007 and its application as a food preservative.

    PubMed

    Ahmad Rather, I; Seo, B J; Rejish Kumar, V J; Choi, U-H; Choi, K-H; Lim, J H; Park, Y-H

    2013-07-01

    Korean kimchi is known for its myriad of lactic acid bacteria (LAB) with diverse bioactive compounds. This study was undertaken to isolate an efficient antifungal LAB strain among the isolated kimchi LABs. One thousand and four hundred LABs isolated from different kimchi samples were initially screened against Aspergillus niger. The strain exhibiting the highest antifungal activity was identified as Lactobacillus plantarum YML007 by 16S rRNA sequencing and biochemical assays using API 50 CHL kit. Lact. plantarum YML007 was further screened against Aspergillus oryzae, Aspergillus flavus, Fusarium oxysporum and other pathogenic bacteria. The morphological changes during the inhibition were assessed by scanning electron microscopy. Preliminary studies on the antifungal compound demonstrated its proteinaceous nature with a molecular weight of 1256·617 Da, analysed by matrix-assisted laser desorption ionization-time-of-flight mass spectrometry (MALDI-TOF). The biopreservative activity of Lact. plantarum YML007 was evaluated using dried soybeans. Spores of A. niger were observed in the negative control after 15 days of incubation. However, fungal growth was not observed in the soybeans treated with fivefold concentrated cell-free supernatant of Lact. plantarum YML007. The broad activity of Lact. plantarum YML007 against various food spoilage moulds and bacteria suggests its scope as a food preservative. After screening 1400 kimchi bacterial isolates, strain Lactobacillus plantarum YML007 was selected with strong antifungal activity against various foodborne pathogens. From the preliminary studies, it was found that the bioactive compound is a low molecular weight novel protein of 1256·617 Da. Biopreservative potential of Lact. plantarum YML007 was demonstrated on soybean grains, and the results point out YML007 as a potent biopreservative having broad antimicrobial activity against various foodborne pathogens. © 2013 The Society for Applied Microbiology.

  12. Silicon-zinc-glycerol hydrogel, a potential immunotropic agent for topical application.

    PubMed

    Khonina, Tat'yana G; Ivanenko, Maria V; Chupakhin, Oleg N; Safronov, Alexander P; Bogdanova, Ekaterina A; Karabanalov, Maxim S; Permikin, Vasily V; Larionov, Leonid P; Drozdova, Lyudmila I

    2017-09-30

    Nanoparticles synthesized using sol-gel method are promising agents for biomedical applications, in particular for the therapy and diagnosis of various diseases. Using silicon and zinc glycerolates as biocompatible precursors we synthesized by the sol-gel method a new bioactive silicon-zinc-containing glycerohydrogel combining the positive pharmacological properties of the precursors. In the present work the structural features of silicon-zinc-containing glycerohydrogel and its immunotropic properties were studied. The advanced physical methods, including XRD, TEM, dynamic and electrophoretic light scattering, were used for studying the structural features of the gel. Hydrolysis of zinc monoglycerolate was investigated under gelation conditions. Evaluation of the efficiency of silicon-zinc-containing glycerohydrogel in providing immune functions was carried out using a model of the complicated wound process behind immunosuppression induced by hydrocortisone administration in the Wistar rats. It has been shown that zinc monoglycerolate exists in the state of amorphous nanoparticles in the cells of 3D-network formed due to incomplete hydrolysis of silicon glycerolates and subsequent silanol condensation. Zinc monoglycerolate is not hydrolyzed and does not enter 3D-network of the gel with the formation of Zn-O-Si groups, but it forms a separate phase. Immunotropic action of silicon-zinc-containing glycerohydrogel was revealed by the histology and immunohistochemistry methods. Amorphous nanoparticles of zinc monoglycerolate, water-soluble silicon glycerolates, and products of their hydrolytic transformations, which are present in a aqueous-glycerol medium, are in the first place responsible for the pharmacological activity of hydrogel. The results obtained allow us to consider silicon-zinc-containing glycerohydrogel as a promising immunotropic agent for topical application. Copyright © 2017 Elsevier B.V. All rights reserved.

  13. In-vitro activity of sodium-hypochlorite gel on bacteria associated with periodontitis.

    PubMed

    Jurczyk, Karolina; Nietzsche, Sandor; Ender, Claudia; Sculean, Anton; Eick, Sigrun

    2016-11-01

    The aim of the present study was to assess the antimicrobial activity of a sodium hypochlorite formulation including its components against bacteria associated with periodontal disease. Sodium hypochlorite formulation (NaOCl gel), its components sodium hypochlorite (NaOCl), and the activating vehicle were compared with 0.1 % chlorhexidine digluconate (CHX) solution. The antimicrobial activity was proven by determination of minimal inhibitory concentrations (MIC), minimal bactericidal concentrations, and killing assays. Furthermore, the influence on formation as well as on a 4-day-old 6-species biofilm was tested. Except for one strain (Parvimonas micra ATCC 33270 in case of NaOCl gel), the MICs both of the CHX solution and NaOCl gel did not exceed 10 % of the formulations' concentration. In general, MICs of the NaOCl gel were equal as of the CHX solution against Gram-negatives but higher against Gram-positive bacteria. CHX but not NaOCl gel clearly inhibited biofilm formation; however, the activity of NaOCl gel was more remarkable on a 4-day-old biofilm. NaOCl killed bacteria in the biofilm and interfered with the matrix. The NaOCl gel acts antimicrobial in particular against Gram-negative species associated with periodontitis. Moreover, its component NaOCl hypochlorite is able to alter biofilm matrices. The NaOCl gel may represent a potential alternative for adjunctive topical antimicrobial treatment in periodontitis.

  14. Nanoemulsion-based gel formulation of diclofenac diethylamine: design, optimization, rheological behavior and in vitro diffusion studies.

    PubMed

    Hamed, Rania; Basil, Marwa; AlBaraghthi, Tamadur; Sunoqrot, Suhair; Tarawneh, Ola

    2016-12-01

    Chronic oral administration of the non-steroidal anti-inflammatory drug, diclofenac diethylamine (DDEA), is often associated with gastrointestinal ulcers and bleeding. As an alternative to oral administration, a nanoemulsion-based gel (NE gel) formulation of DDEA was developed for topical administration. An optimized formulation for the o/w nanoemulsion of oil, surfactant and cosurfactant was selected based on nanoemulsion mean droplet size, clarity, stability, and flowability, and incorporated into the gelling agent Carbopol® 971P. Rheological studies of the DDEA NE gel were conducted and compared to those of conventional DDEA gel and emulgel. The three gels exhibited an elastic behavior, where G' dominated G″ at all frequencies, indicating the formation of strong gels. NE gel exhibited higher G' values than conventional gel and emulgel, which indicated the formation of a stronger gel network. Strat-M® membrane, a synthetic membrane with diffusion characteristics that are well correlated to human skin, was used for the in vitro diffusion studies. The release of DDEA from conventional gel, emulgel and NE gel showed a controlled release pattern over 12 h, which was consistent with the rheological properties of the gels. DDEA release kinetics from the three gels followed super case II transport as fitted by Korsmeyer-Peppas model.

  15. Topical Antimycotics for Oral Candidiasis in Warfarin Users.

    PubMed

    Hellfritzsch, Maja; Pottegård, Anton; Pedersen, Andreas James Thestrup; Burghle, Alaa; Mouaanaki, Fatima; Hallas, Jesper; Grove, Erik Lerkevang; Damkier, Per

    2017-04-01

    Treatment for oral candidiasis in warfarin users may be complicated by drug-drug interactions (DDIs) between warfarin and topically applied antimycotics. However, current knowledge of these putative DDIs is merely based on case series. We therefore performed a cohort cross-over study with the objective to evaluate the potential DDIs between warfarin and miconazole oral gel or nystatin oral solution. The cohort consisted of individuals using warfarin in the period of 1998-2012 (n ≈ 7400). We collected data on cohort members' measurements of the international normalized ratio (INR) from a clinical database, and obtained information on their use of topically applied miconazole and nystatin from a regional prescription register. Potential DDIs were assessed by comparing INR values before and after initiation of an antimycotic drug. Among 17 warfarin users exposed to miconazole oral gel, the mean INR increased from 2.5 (95% CI: 2.1-2.8) to 3.8 (95% CI: 2.8-4.8) after exposure, corresponding to a mean INR increase of 1.4 (95% CI: 0.3-2.4). Among 30 warfarin users exposed to nystatin oral solution, the mean INR was 2.7 (95% CI: 2.3-3.1) before and 2.5 (95% CI: 2.2-2.9) after exposure. In conclusion, we found evidence supporting a clinically relevant drug-drug interaction between warfarin and miconazole oral gel. In contrast, we did not find any indication of an interaction between warfarin and nystatin oral solution. Nystatin rather than miconazole should be preferred when treating warfarin users for oral candidiasis. © 2016 Nordic Association for the Publication of BCPT (former Nordic Pharmacological Society).

  16. Time-dependent gel to gel transformation of a peptide based supramolecular gelator.

    PubMed

    Baral, Abhishek; Basak, Shibaji; Basu, Kingshuk; Dehsorkhi, Ashkan; Hamley, Ian W; Banerjee, Arindam

    2015-06-28

    A dipeptide with a long fatty acid chain at its N-terminus gives hydrogels in phosphate buffer in the pH range 7.0-8.5. The hydrogel with a gelator concentration of 0.45% (w/v) at pH 7.46 (physiological pH) provides a very good platform to study dynamic changes within a supramolecular framework as it exhibits remarkable change in its appearance with time. Interestingly, the first formed transparent hydrogel gradually transforms into a turbid gel within 2 days. These two forms of the hydrogel have been thoroughly investigated by using small angle X-ray scattering (SAXS), powder X-ray diffraction (PXRD), field emission scanning electron microscopic (FE-SEM) and high-resolution transmission electron microscopic (HR-TEM) imaging, FT-IR and rheometric analyses. The SAXS and low angle PXRD studies substantiate different packing arrangements for the gelator molecules for these two different gel states (the freshly prepared and the aged hydrogel). Moreover, rheological studies of these two gels reveal that the aged gel is stiffer than the freshly prepared gel.

  17. CCI-007, a novel small molecule with cytotoxic activity against infant leukemia with MLL rearrangements

    PubMed Central

    Middlemiss, Shiloh M.C.; Wen, Victoria W.; Clifton, Molly; Kwek, Alan; Liu, Bing; Mayoh, Chelsea; Bongers, Angelika; Karsa, Mawar; Pan, Sukey; Cruikshank, Sarah; Scandlyn, Marissa; Hoang, Wendi; Imamura, Toshihiko; Kees, Ursula R.; Gudkov, Andrei V.; Chernova, Olga B.

    2016-01-01

    There is an urgent need for the development of less toxic, more selective and targeted therapies for infants with leukemia characterized by translocation of the mixed lineage leukemia (MLL) gene. In this study, we performed a cell-based small molecule library screen on an infant MLL-rearranged (MLL-r) cell line, PER-485, in order to identify selective inhibitors for MLL-r leukemia. After screening initial hits for a cytotoxic effect against a panel of 30 cell lines including MLL-r and MLL wild-type (MLL-wt) leukemia, solid tumours and control cells, small molecule CCI-007 was identified as a compound that selectively and significantly decreased the viability of a subset of MLL-r and related leukemia cell lines with CALM-AF10 and SET-NUP214 translocation. CCI-007 induced a rapid caspase-dependent apoptosis with mitochondrial depolarization within twenty-four hours of treatment. CCI-007 altered the characteristic MLL-r gene expression signature in sensitive cells with downregulation of the expression of HOXA9, MEIS1, CMYC and BCL2, important drivers in MLL-r leukemia, within a few hours of treatment. MLL-r leukemia cells that were resistant to the compound were characterised by significantly higher baseline gene expression levels of MEIS1 and BCL2 in comparison to CCI-007 sensitive MLL-r leukemia cells. In conclusion, we have identified CCI-007 as a novel small molecule that displays rapid toxicity towards a subset of MLL-r, CALM-AF10 and SET-NUP214 leukemia cell lines. Our findings suggest an important new avenue in the development of targeted therapies for these deadly diseases and indicate that different therapeutic strategies might be needed for different subtypes of MLL-r leukemia. PMID:27317766

  18. Comparison of the transdermal absorption of nimesulide from three commercially available gel formulations.

    PubMed

    Dayal, Pankaj; Kanikkannan, Narayanasamy; Singh, Amarjit; Sing, Mandip

    2002-03-01

    Nimesulide is a non-steroidal anti-inflammatory drug (NSAID) applied topically for a variety of conditions characterized by pain and inflammation. One of the aims of this study was to compare the permeation profile of nimesulide from the commercially available transdermal gel formulations across dermatomed porcine and human skin. The in vitro transdermal absorption of nimesulide formulations across porcine skin and human skin was studiedfor 24 hr using a continuous flow-through diffusion cell. The three commercial gels used in this study were Nimulid, Nise Gel, and Orthobid. All gels contained 1% (w/w) nimesulide. An infinite dose of nimesulide gel (about 300mg) was applied on the skin over 0.636 cm2 surface area. The rank order for the drug permeation from these formulations using porcine skin was: Nimulid > Orthobid > Nise Gel. The rank order of the permeation across human skin was: Nimulid> Nise Gel> Orthobid. The permeation profiles followed zero-order kinetics without any significant lag time. The steady-state flux of nimesulide from Nimulid was significantly higher than that of Nise Gel and Orthobid in both porcine and human skin (p <.05). However, there were no significant differences in the delivery of nimesulide (24 hr) from Nise Gel and Orthobid across both human and porcine skins. The results suggest that the Nimulid gel may have a greater bioavailability of nimesulide compared to the other gels. In addition, permeation profiles of the various gels across porcine skin did show a positive profile behavior to human skin. However, the in vitro drug release of nimesulide gels across a synthetic membrane did not correlate with skin permeation profiles.

  19. Dynamics of a DNA Gel

    NASA Astrophysics Data System (ADS)

    Adhikari, Ramesh; Bhattacharya, Aniket; Dogariu, Aristide

    We study in silico the properties of a gel consisting of DNA strands (modeled as semi-flexible chains) and linkers of varying flexibility, length, and topology. These linkers are envisioned and modeled as active components with additional attributes so as to mimic properties of a synthetic DNA gel containing motor proteins. We use Brownian dynamics to directly obtain frequency dependent complex shear moduli of the gel. We further carry out force spectroscopy on these computer generated gels and study the relaxation properties as a function of the important parameters of the model, e.g., densities and relative ratios of the DNAs and the linkers, the average life time of a link, etc. Our studies are relevant for designing synthetic bio-materials for both materials and medical applications.

  20. MTN-017: A Rectal Phase 2 Extended Safety and Acceptability Study of Tenofovir Reduced-Glycerin 1% Gel

    PubMed Central

    Lama, Javier R.; Richardson, Barbra A.; Carballo-Diéguez, Alex; Kunjara Na Ayudhya, Ratiya Pamela; Liu, Karen; Patterson, Karen B.; Leu, Cheng-Shiun; Galaska, Beth; Jacobson, Cindy E.; Parikh, Urvi M.; Marzinke, Mark A.; Hendrix, Craig W.; Johnson, Sherri; Piper, Jeanna M.; Grossman, Cynthia; Ho, Ken S.; Lucas, Jonathan; Pickett, Jim; Bekker, Linda-Gail; Chariyalertsak, Suwat; Chitwarakorn, Anupong; Gonzales, Pedro; Holtz, Timothy H.; Liu, Albert Y.; Mayer, Kenneth H.; Zorrilla, Carmen; Schwartz, Jill L.; Rooney, James; McGowan, Ian

    2017-01-01

    Abstract Background. Human immunodeficiency virus (HIV) disproportionately affects men who have sex with men (MSM) and transgender women (TGW). Safe and acceptable topical HIV prevention methods that target the rectum are needed. Methods. MTN-017 was a phase 2, 3-period, randomized sequence, open-label, expanded safety and acceptability crossover study comparing rectally applied reduced-glycerin (RG) 1% tenofovir (TFV) and oral emtricitabine/TFV disoproxil fumarate (FTC/TDF). In each 8-week study period participants were randomized to RG-TFV rectal gel daily, or RG-TFV rectal gel before and after receptive anal intercourse (RAI; or at least twice weekly in the event of no RAI), or daily oral FTC/TDF. Results. MSM and TGW (n = 195) were enrolled from 8 sites in the United States, Thailand, Peru, and South Africa with mean age of 31.1 years (range 18-64). There were no differences in ≥grade 2 adverse event rates between daily gel (incidence rate ratio [IRR], 1.09; P = .59) or RAI gel (IRR, 0.90; P = .51) compared to FTC/TDF. High adherence (≥80% of prescribed doses assessed by unused product return and Short Message System reports) was less likely in the daily gel regimen (odds ratio [OR], 0.35; P < .001), and participants reported less likelihood of future daily gel use for HIV protection compared to FTC/TDF (OR, 0.38; P < .001). Conclusions. Rectal application of RG TFV gel was safe in MSM and TGW. Adherence and product use likelihood were similar for the intermittent gel and daily oral FTC/TDF regimens, but lower for the daily gel regimen. Clinical Trials Registration: NCT01687218. PMID:27986684

  1. Topical dihydrotestosterone to treat micropenis secondary to partial androgen insensitivity syndrome (PAIS) before, during, and after puberty - a case series.

    PubMed

    Becker, David; Wain, Lisa M; Chong, Yih Harng; Gosai, Sonal J; Henderson, Nina K; Milburn, Jacqui; Stott, Victoria; Wheeler, Benjamin J

    2016-02-01

    X-linked partial androgen insensitivity syndrome (PAIS) causes under-virilization at all stages of development. In two thirds of males, this results in micropenis. Dihydrotestosterone (DHT) is a potent androgen that is critical for male genital development, which when applied topically, has been shown to increase penile length with micropenis of varying etiologies. We present the first case series using topical DHT gel to treat micropenis in 46,XY males with PAIS, before, during, and after puberty. Three related 46,XY males with confirmed p.L712F androgen receptor mutations exhibited varying degrees of micropenis post-surgical correction. They were of pre-pubertal, peri-pubertal and adult ages, respectively. Following baseline clinical and laboratory assessments all completed a 4-month course of daily DHT gel 2.5% (androstanolone) topically to penis (0.3 mg/kg body weight), with monitoring for adverse effects. Primary outcome was change in stretched penile length (SPL) following treatment. Mixed results were obtained following topical DHT therapy. In the pre- and peri- pubertal patients, SPL changed from 2.5 cm to 3.5 cm (+40%), and 3.5 cm to 5.7 cm (+63%), respectively. In the adult patient with 1 year of prior high-dose weekly testosterone therapy, no additional change in SPL was seen. No adverse effects of topical DHT were reported or observed throughout the 4 months of treatment. Topical DHT treatment appears to be a safe and well-tolerated method of virilising micropenis both prior to and during puberty in children with PAIS. Questions remain about long-term outcomes into adulthood, and efficacy in adults with prior lengthy exposure to high-dose testosterone.

  2. Evaluation of the efficacy and safety of a CS20® protective barrier gel containing OGT compared with topical aciclovir and placebo on functional and objective symptoms of labial herpes recurrences: a randomized clinical trial.

    PubMed

    Khemis, A; Duteil, L; Coudert, A C; Tillet, Y; Dereure, O; Ortonne, J P

    2012-10-01

    Topical or systemic antiviral drugs reduce the duration of herpes simplex virus 1 (HSV-1) recurrences but may not alleviate functional symptoms. To assess the efficacy and safety of CS20 (Acura 24(®) ) protective barrier gel versus topical aciclovir and placebo in resolving functional symptoms in HSV-1 labial recurrences. A prospective, randomized, single-centre, assessor-blinded study of CS20 versus topical aciclovir or placebo. The primary endpoint was the total score of four herpes-related functional symptoms (pain, burning, itching, and tingling sensations), evaluated by visual analogue scale (VAS). Secondary endpoints encompassed objective skin changes (oedema, crusting and erythema), evaluated by specific clinical scores. In a study of 106 patients, compared with placebo, a significant improvement in total functional symptom score was observed after 1 day of treatment in the CS20 group, but only after 7 days of treatment in the topical aciclovir group. Burning sensations were significantly reduced by CS20 compared with aciclovir (Days 1-2) or placebo (Days 1-7). Compared to placebo, CS20 significantly reduced pain intensity on Days 1-6. CS20 induced significant and early improvements in the clinical scores for oedema and crusting compared with placebo. Time to cure was similar for CS20 and aciclovir. The treatments were well tolerated and adverse events were comparable in the three treatment groups. Limitations  The single-centre and single-blind design of the study and the preselection of patients. CS20 showed superior effectiveness against functional symptoms (pain and burning) associated with HSV-1 labial recurrences and was similar to aciclovir for time to cure. © 2011 The Authors. Journal of the European Academy of Dermatology and Venereology © 2011 European Academy of Dermatology and Venereology.

  3. Dopamine Transporter-Dependent and -Independent Striatal Binding of the Benztropine Analog JHW 007, a Cocaine Antagonist with Low Abuse Liability

    PubMed Central

    Kopajtic, Theresa A.; Liu, Yi; Surratt, Christopher K.; Donovan, David M.; Newman, Amy H.; Katz, Jonathan L.

    2010-01-01

    The benztropine analog N-(n-butyl)-3α-[bis(4′-fluorophenyl)methoxy]-tropane (JHW 007) displays high affinity for the dopamine transporter (DAT), but unlike typical DAT ligands, has relatively low abuse liability and blocks the effects of cocaine, including its self-administration. To determine sites responsible for the cocaine antagonist effects of JHW 007, its in vitro binding was compared with that of methyl (1R,2S,3S,5S)-3-(4-fluorophenyl)-8-methyl-8-azabicyclo[3.2.1]octane-2-carboxylate (WIN 35428) in rats, mice, and human DAT (hDAT)-transfected cells. A one-site model, with Kd values of 4.21 (rat) and 8.99 nM (mouse) best fit the [3H]WIN 35428 data. [3H]JHW 007 binding best fit a two-site model (rat, 7.40/4400 nM; mouse, 8.18/2750 nM), although a one-site fit was observed with hDAT membranes (43.7 nM). Drugs selective for the norepinephrine and serotonin transporters had relatively low affinity in competition with [3H]JHW 007 binding, as did drugs selective for other sites identified previously as potential JHW 007 binding sites. The association of [3H]WIN 35428 best fit a one-phase model, whereas the association of [3H]JHW 007 best fit a two-phase model in all tissues. Because cocaine antagonist effects of JHW 007 have been observed previously soon after injection, its rapid association observed here may contribute to those effects. Multiple [3H]JHW 007 binding sites were obtained in tissue from mice lacking the DAT, suggesting these as yet unidentified sites as potential contributors to the cocaine antagonist effects of JHW 007. Unlike WIN 35428, the binding of JHW 007 was Na+-independent. This feature of JHW 007 has been linked to the conformational status of the DAT, which in turn may contribute to the antagonism of cocaine. PMID:20855444

  4. Arginine functionalized bacterial cellulose nanofibers containing gel as an effective wound dressing; in vitro and in vivo evaluation.

    PubMed

    Feizabadi, Farideh; Minaiyan, Mohsan; Taheri, Azade

    2018-02-19

    Nanofibers such as bacterial cellulose nanofibers (BC-NFs) have gained increasing attention for use in wound dressings. Topical application of arginine can stimulate wound healing significantly. In order to promote the wound healing process, arginine functionalized BC-NFs containing gel (Arg-BC-NFs gel) was prepared by the electrostatic attachment of arginine on the surface of BC-NFs. The effect of pH was evaluated on the amount of the attached arginine on the BC-NFs surface. The attachment of arginine on BC-NFs surface was investigated by FTIR spectroscopy. The morphology of Arg-BC-NFs was evaluated using FESEM. The viscosity and spreadability of Arg-BC-NFs and the release of arginine from Arg-BC-NFs were evaluated. The effectiveness of Arg-BC-NFs gel was assessed in a full thickness wound model in rats. Re-epithelization, collagen deposition and neovascularization were investigated in the wound tissues using histological and immunohistochemical analysis. FTIR spectra and the zeta potential of BC-NFs confirmed the surface modification of BC-NFs by arginine. FESEM images showed the nanofibrous structure of Arg-BC-NFs. The release of arginine from Arg-BC-NFs gel was in a sustained release manner for 24 h. The appropriate viscosity and spreadability of Arg-BC-NFs gel confirmed its easy topical application. In vivo studies revealed that Arg-BC-NFs gel promoted wound closure at a faster rate than BC-NFs gel and arginine solution. Moreover, faster and more organized re-epithelialization, angiogenesis and collagen deposition were achieved in Arg-BC-NFs gel treated group in comparison to other groups. Arg-BC-NFs gel can be introduced as an effective wound dressing for acute wounds. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

  5. Efficacy and Safety of Tazarotene 0.1% Plus Clindamycin 1% Gel Versus Adapalene 0.1% Plus Clindamycin 1% Gel in Facial Acne Vulgaris: A Randomized, Controlled Clinical Trial.

    PubMed

    Maiti, Rituparna; Sirka, Chandra Sekhar; Ashique Rahman, M A; Srinivasan, Anand; Parida, Sansita; Hota, Debasish

    2017-11-01

    Acne vulgaris is a multifactorial disorder which is ideally treated with combination therapy with topical retinoids and antibiotics. The present study was conducted to compare the efficacy and safety of tazarotene plus clindamycin against adapalene plus clindamycin in facial acne vulgaris. This study is a randomized, open-label, parallel design clinical trial conducted on 60 patients with facial acne at the outpatient dermatology department in a tertiary healthcare center. The main outcome measures were change in the acne lesion count, Investigator's Static Global Assessment (ISGA) score, Global Acne Grading System (GAGS) score, and Acne-Specific Quality of Life Questionnaire (Acne-QoL) at the end of 4 weeks of therapy. After randomization one group (n = 30) received tazarotene 0.1% plus clindamycin 1% gel and another group (n = 30) received adapalene 0.1% plus clindamycin 1% gel for 1 month. At follow-up, all the parameter were reassessed. In both treatment regimens the total number of facial acne lesions decreased significantly. The difference in the change in the total count between the two combination regimens was also significant [6.51, 95% confidence interval (CI) 1.91-11.09, p = 0.007]. A ≥50% reduction in the total lesion count from the baseline levels was achieved by 71% of patients in the tazarotene plus clindamycin group and 22% of patients in the adapalene plus clindamycin group (p = 0.0012). The difference in the change of inflammatory (p = 0.017) and non-inflammatory (p = 0.039) lesion counts in the tazarotene plus clindamycin group were significantly higher than the adapalene plus clindamycin group. The difference in change of the GAGS score was also significantly higher in the tazarotene plus clindamycin group (p = 0.003). The ISGA score improved in 17 patients in the tazarotene plus clindamycin group versusnine patients in the adapalene plus clindamycin group (p = 0.04). The change of total quality-of-life score was found to be

  6. Absence of Degradation of Tretinoin When Benzoyl Peroxide is Combined with an Optimized Formulation of Tretinoin Gel (0.05%)

    PubMed Central

    Pillai, Radhakrishnan; Moore, Robert

    2010-01-01

    Background: Clinicians have been reluctant to prescribe benzoyl peroxide concurrently with topical tretinoin due to a belief that the benzoyl peroxide may cause oxidation and degradation of the tretinoin molecule, thereby reducing its effectiveness. However, benzoyl peroxide-induced degradation of tretinoin may not necessarily apply to all topical tretinoin formulations. Objective: To evaluate the potential for benzoyl peroxide-induced degradation of an optimized aqueous gel formulation of tretinoin (0.05%). Methods: Tretinoin gel (0.05%) and benzoyl peroxide gel (6.26% premix concentration to produce 5% benzoyl peroxide in a fixed combination clindamycin product) were mixed together (1:1) at 32ºC and samples assayed after 1, 2, 3, 5, and 7 hours. Each sample was analyzed for tretinoin (expressed as % tretinoin remaining) and its degradation product content. Results: No loss of tretinoin was observed over the seven-hour time period. When tretinoin gel (0.05%) was combined with benzoyl peroxide, 100 percent of the initial tretinoin concentration remained after seven hours. There was no increase in the degradation products of tretinoin. Conclusions: There was no benzoyl peroxide-induced degradation of tretinoin when the optimized formulation of tretinoin gel (0.05%) was admixed with benzoyl peroxide gel (6.26%). Although the direct clinical significance of these results is unknown, clinicians may feel comfortable using this particular combination concurrently without concerns about tretinoin oxidation and degradation. PMID:20967192

  7. 46 CFR 164.007-5 - Test requirements.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... thermocouples on the unexposed surface described in § 164.007-4(f)(2) will not rise more than 139 °C. (250 °F... through metallic connection, rise more than 181 °C. (325 °F.) above the original temperature at the end of...

  8. 46 CFR 164.007-5 - Test requirements.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... thermocouples on the unexposed surface described in § 164.007-4(f)(2) will not rise more than 139 °C. (250 °F... through metallic connection, rise more than 181 °C. (325 °F.) above the original temperature at the end of...

  9. Synthesis and characterization of novel Ce{sub 0.8}Sm{sub 0.2}Fe{sub 0.9}Ir{sub 0.03}Co{sub 0.07}O{sub 3−δ} perovskite material and possible application as a cathode for low–intermediate temperature SOFCs

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Njoku, Chima Benjamin; Ndungu, Patrick Gathura, E-mail: ndungup@ukzn.ac.za

    2015-08-15

    Highlights: • Ce{sub 0.8}Sm{sub 0.2}Fe{sub 0.9}Ir{sub 0.03}Co{sub 0.07}O{sub 3−δ} was synthesized using sol–gel methods. • Material was thoroughly characterized using Raman, FTIR, XRD, HRTEM, SEM, and TGA. • Electrochemical performance showed the materials are a promising new cathode material for low temperature SOFC. - Abstract: A novel perovskite material, Ce{sub 0.8}Sm{sub 0.2}Fe{sub 0.9}Ir{sub 0.03}Co{sub 0.07}O{sub 3−δ} was synthesized using a sol–gel technique. The materials were calcined at temperatures of 800 °C, 900 °C, and 1000 °C and then characterized using X-ray diffraction, Raman and infrared spectroscopy, high resolution transmission electron microscopy and scanning electron microscopy (SEM). The particle sizes andmore » crystallite sizes increased with increasing calcination temperature and formed perovskite type materials with some separate magnetite and iridium oxide. The powders were used to assemble button cells using samarium doped ceria as the electrolyte and NiO/SDC as the anode materials. The electrochemical properties were investigated using a Fiaxell open flanges test set-up and a Nuvant™ Powerstat-05 potentiostat/galvanostat. The Ce{sub 0.8}Sm{sub 0.2}Fe{sub 0.9}Ir{sub 0.03}Co{sub 0.07}O{sub 3−δ} cathode material calcined at 1000 °C exhibited the most promising performance, with a maximum power density of 0.400 W/cm{sup 2}, a current density of 0.8 A/cm{sup 2}, and a corresponding area specific resistance of 0.247 Ωcm{sup 2} at 500 °C. The button cells were reasonably stable over15 h.« less

  10. 46 CFR 159.007-11 - Production inspections and tests: Yearly report.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 46 Shipping 6 2010-10-01 2010-10-01 false Production inspections and tests: Yearly report. 159.007-11 Section 159.007-11 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) EQUIPMENT, CONSTRUCTION, AND MATERIALS: SPECIFICATIONS AND APPROVAL APPROVAL OF EQUIPMENT AND MATERIALS Production Inspection and Tests of Approved Equipment an...

  11. 46 CFR 159.007-11 - Production inspections and tests: Yearly report.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 46 Shipping 6 2011-10-01 2011-10-01 false Production inspections and tests: Yearly report. 159.007-11 Section 159.007-11 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) EQUIPMENT, CONSTRUCTION, AND MATERIALS: SPECIFICATIONS AND APPROVAL APPROVAL OF EQUIPMENT AND MATERIALS Production Inspection and Tests of Approved Equipment an...

  12. Transdermal delivery of paeonol using cubic gel and microemulsion gel

    PubMed Central

    Luo, Maofu; Shen, Qi; Chen, Jinjin

    2011-01-01

    Background The aim of this study was to develop new systems for transdermal delivery of paeonol, in particular microemulsion gel and cubic gel formulations. Methods Various microemulsion vehicles were prepared using isopropyl myristate as an oil phase, polyoxyethylated castor oil (Cremophor® EL) as a surfactant, and polyethylene glycol 400 as a cosurfactant. In the optimum microemulsion gel formulation, carbomer 940 was selected as the gel matrix, and consisted of 1% paeonol, 4% isopropyl myristate, 28% Cremophor EL/polyethylene glycol 400 (1:1), and 67% water. The cubic gel was prepared containing 3% paeonol, 30% water, and 67% glyceryl monooleate. Results A skin permeability test using excised rat skins indicated that both the cubic gel and microemulsion gel formulations had higher permeability than did the paeonol solution. An in vivo pharmacokinetic study done in rats showed that the relative bioavailability of the cubic gel and microemulsion gel was enhanced by about 1.51-fold and 1.28-fold, respectively, compared with orally administered paeonol suspension. Conclusion Both the cubic gel and microemulsion gel formulations are promising delivery systems to enhance the skin permeability of paeonol, in particular the cubic gel. PMID:21904450

  13. Rheological effect of gamma radiation on gel-like formulation: Appraisal for the construction of radiopharmaceuticals for cutaneous application

    NASA Astrophysics Data System (ADS)

    Saez, Vivian; Khoury, Helen Jamil; da Silva, Maria Isabel Barbosa; Mansur, Claudia Regina Elias; Santos-Oliveira, Ralph

    2018-04-01

    Skin cancer affects a lot of people being a malignant cutaneous melanoma one of the most aggressive neoplasms. Nowadays, the FDA-approved drugs to treat them are not as efficient as needed. Thus, the development of new agents or treatments is quite urgent. In that sense, the use of radioactive materials could represent a good alternative and especially Radium-223 is already been explored with promising results. Here, a Carbopol gel-like formulation was designed and irradiated with different doses in order to prove that it is suitable to include Radium-223 for its combined application by topic route. A formulation was obtained by the addition of triethanolamine to the Carbopol solution until pH 5.0. Physical and rheological tests showed that the formulation is a weak gel with a proper consistence to be administered by both routes. The formulation kept its appearance of transparent gel without change in color, presence of grits or syneresis after all tratments. The microstructure of gels was only slightly modified when the irradiation was made with 1000 Gy while the spreadability and viscosity were more deeply affected. Since the properties of this Carbopol gel-like formulation were maintained under irradiation doses until 100 Gy it is possible to consider that the formulation is suitable to include Radium-223 in order to evaluate its performance as localized drug delivery system for topical administration.

  14. 46 CFR 164.007-6 - Test report.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... temperature, for each thermocouple together with curves of average temperature for the unexposed surface of the insulation and the thermocouple recording the highest temperature. In addition, for § 164.007-9(g... and each surface of insulation thermocouple together with the initial temperature of each thermocouple...

  15. 46 CFR 164.007-6 - Test report.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... temperature, for each thermocouple together with curves of average temperature for the unexposed surface of the insulation and the thermocouple recording the highest temperature. In addition, for § 164.007-9(g... and each surface of insulation thermocouple together with the initial temperature of each thermocouple...

  16. Effects of a herbal gel containing carvacrol and chalcones on alveolar bone resorption in rats on experimental periodontitis.

    PubMed

    Botelho, Marco Antonio; Rao, Vietla Satyanarayana; Montenegro, Danusa; Bandeira, Mary Anne Menezes; Fonseca, Said Gonçalves Cruz; Nogueira, Nadia Accioly Pinto; Ribeiro, Ronaldo Albuquerque; Brito, Gerly Anne Castro

    2008-04-01

    Carvacrol and dimeric chalcones are the respective bioactive components of Lippia sidoides and Myracrodruon urundeuva, popular medicinal plants of Northeastern Brazil with proven antimicrobial and antiinflammatory properties. Periodontal disease is associated with inflammation and microbiological proliferation, thus the study aimed to investigate the effect of a topical gel based on carvacrol and chalcones in the experimental periodontal disease (EPD) in rats. Animals were treated with carvacrol and/or chalcones gel, immediately after EPD induction, three times a day for 11 days. Appropriate controls were included in the study. Animals were weighed daily. They were killed on day 11, the mandibles dissected and alveolar bone loss was measured. The periodontium were examined at histopathology and the neutrophil influx into the gingiva was assayed using myeloperoxidase activity. The bacterial flora were assessed through culture of the gingival tissue. Alveolar bone loss was significantly (p < 0.05) inhibited by combined carvacrol and chalcones gel, compared with the vehicle and non-treated groups. The treatment with the combined gel reduced tissue lesion at histopathology, decreased myeloperoxidase activity in gingival tissue and inhibited the growth of oral microorganisms as well as the weight loss. Carvacrol and chalcones combination gel has a beneficial effect upon EPD in this model. (c) 2008 John Wiley & Sons, Ltd.

  17. Nanoemulsion-based gel formulations of COX-2 inhibitors for enhanced efficacy in inflammatory conditions

    NASA Astrophysics Data System (ADS)

    Lala, R. R.; Awari, N. G.

    2014-02-01

    In the present study, we have investigated the potential of a nanoemulsion (thermodynamically stable transparent dispersions of oil and water having a droplet size <200 nm) formulation for the topical delivery of COX-2 inhibitors using etoricoxib as a model drug. Various oil-in-water nanoemulsions were prepared by the spontaneous emulsification method. The nanoemulsion area was identified by constructing pseudo-ternary phase diagrams. The prepared nanoemulsions were subjected to thermodynamic stability testing. Those that passed these tests were characterized for viscosity, droplet size and differential scanning calorimetry. Topical permeation of etoricoxib through porcine abdominal skin was estimated using the Franz diffusion cell. The ex vivo skin permeation profile of optimized formulations was compared with that of etoricoxib conventional gel. A significant increase in permeability was observed in optimized nanoemulsion formulations consisting of 2 % w/w of etoricoxib, 20 % w/w of Triacetin, 38 % w/w of a surfactant mixture (Cremophor RH 40:Transcutol P), and 42 % w/w of water. The anti-inflammatory effects of this formulation on carrageenan-induced paw edema in rats showed a significant increase in the percent inhibition value (84.61 % with the nanoemulsion gel and 92.30 % with the nanoemulsion) as compared with the conventional gel (69.23 %) after 6 h when compared with etoricoxib conventional gel. These results suggest that nanoemulsions can serve as potential vehicles for improved transdermal delivery of anti-inflammatory agents such as etoricoxib.

  18. Combination therapies in adjuvant with topical ALA-mediated photodynamic therapy for DMBA-induced hamster buccal pouch premalignant lesions

    NASA Astrophysics Data System (ADS)

    Yang, Deng-Fu; Hsu, Yih-Chih

    2012-03-01

    In Taiwan, oral cancer has becomes the fastest growth male cancer disease due to the betel nut chewing habit combing with smoking and alcohol-drinking lifestyle of people. In order to eliminate the systemic phototoxic effect of 5-aminolevulinic acid (ALA), this study was designed to use a topical ALA-mediated PDT for treatment of DMBA-induced hamster buccal pouch precancerous lesions. DMBA was applied to one of the buccal pouches of hamsters thrice a week for 10 to 12 weeks. Cancerous lesions were induced and proven by histological examination. These DMBA-induced cancerous lesions were used for testing the efficacy of topical ALA-mediated PDT. Before PDT, fluorescence spectroscopy was used to determine when ALA reached its peak level in the lesional epithelial cells after topical application of ALA gel. We found that ALA reached its peak level in precancerous lesions about 2.5 hrs after topical application of ALA gel. The cancerous lesions in hamsters were then treated with topical ALA -mediated PDT with light exposure dose of 150 J/cm2 using LED 635 nm fiber-guided light device. Visual examination demonstrated that adjuvant topical ALA -mediated PDT group has shown better therapeutic results in compared to those of non-adjuvant topical ALA-mediated PDT group for DMBA-induced hamster buccal pouch precancerous lesions.

  19. Effectiveness of silica based sol-gel microencapsulation method for odorants and flavors leading to sustainable environment.

    PubMed

    Ashraf, Muhammad Aqeel; Khan, Aysha Masood; Ahmad, Mushtaq; Sarfraz, Maliha

    2015-01-01

    Microencapsulation has become a hot topic in chemical research. Technology mainly used for control release and protection purposes. The sol-gel micro encapsulation approach for fragrance and aroma in porous silica-based materials leads to sustainable odorant and flavored materials with novel and unique beneficial properties. Sol-gel encapsulation of silica based micro particles considered economically cheap as capital investment in manufacturing is very low and environmentally friendly. Amorphous sol-gel SiO2 is non-toxic and safe, whereas the sol-gel entrapment of delicate chemicals in its inner pores results in pronounced chemical and physical stabilization of the entrapped active agents, thereby broadening the practical utilization of chemically unstable essential oils (EOs). Reviewing progress in the fabrication of diverse odorant and flavored sol-gels, shows us how different synthetic strategies are appropriate for practical application with important health and environmental benefits.

  20. Effect of a mucoadhesive gel and dental scaling on gingivitis in dogs.

    PubMed

    Bonello, D; Squarzoni, P

    2008-03-01

    Twenty client-owned dogs diagnosed with gingivitis were studied over a 45-day period in order to investigate the effect of professional dental prophylaxis combined with the use of a topical mucoadhesive gel containing adelmidrol, an aliamide. A non-intrusive papillary-marginal-gingival index (PMGI) was measured at each assessment, while the gingivitis index (GI) was measured only at the beginning and end of the study. Compared to the control group, the treated dogs had a significant decrease (P < 0.005) in the average GI index during the course of the study. A significant reduction (P < 0.002) in the average PMGI index was observed in both groups 15-days following dental prophylaxis. However at 30 and 45-days following dental prophylaxis, the PMGI index values were significantly different (P < 0.005) from baseline only in treated dogs. These results suggest that the combined use of a mucoadhesive gel with dental scaling was able to improve the regression of gingival inflammation and lengthen the therapeutic benefits of dental scaling and polishing during a limited study period.

  1. Dapsone for topical use in extemporaneous preparations.

    PubMed

    Wohlrab, Johannes; Michael, Julia

    2018-01-01

    The sulfone dapsone has an established role in systemic therapy. Its pharmacological and toxicological properties are well known. Topically, dapsone is used in a gel formulation for the treatment of acne vulgaris. In addition, there have been individual case reports on the efficacy of topical dapsone preparations in the treatment of various neutrophilic dermatoses. To date, no finished medicinal product for topical use has been available in Germany. Against this background, we set out to develop extemporaneous preparations containing dapsone (5 %) that meet the quality requirements of the European Pharmacopoeia as well as the manufacturing requirements of the German Ordinance on the Operation of Pharmacies (ApBetrO). These formulations included the incorporation of dapsone in a hydrophobic cream base ("hydrophobe Basiscreme DAC") as well as in methylprednisolone aceponate 0.1 % ointment (alternatively, in the latter's cream base without active ingredient). Tests aimed at investigating the physical, chemical, and microbiological stability of these formulations showed them to meet the aforementioned quality requirements. The extemporaneous formulations presented herein broaden the therapeutic options for topical treatment, in particular for patients with chronic inflammatory dermatoses associated with a neutrophilic pathogenesis. © 2017 Deutsche Dermatologische Gesellschaft (DDG). Published by John Wiley & Sons Ltd.

  2. Healing acceleration in hamsters of oral mucositis induced by 5-fluorouracil with topical Calendula officinalis.

    PubMed

    Tanideh, Nader; Tavakoli, Parisa; Saghiri, Mohammad Ali; Garcia-Godoy, Franklin; Amanat, Dariush; Tadbir, Azadeh Andisheh; Samani, Soleiman Mohammadi; Tamadon, Amin

    2013-03-01

    This study assessed the potential of topical Calendula officinalis extract on the healing of oral mucositis induced by 5-fluorouracil (5-FU) in hamsters. Oral mucositis was induced in 60 male hamsters by 5-FU (60 mg/kg) on days 0, 5, and 10 of the study. The cheek pouch was scratched with a sterile needle on days 1 and 2. On days 12-17, 5% and 10% C. officinalis gel and gel base groups were treated and then compared with a control group. Macroscopic and microscopic scores and weights were evaluated. Microscopic and macroscopic scores of mucositis were lower in the 5% and 10% C. officinalis gel groups than in the gel base and control groups (P < .05). Weight gain was noted in the treatment groups compared with the gel base and control groups (P < .05). Calendula officinalis extract accelerated the healing of oral mucositis in hamsters. Copyright © 2013 Elsevier Inc. All rights reserved.

  3. IMM-H007, a new therapeutic candidate for nonalcoholic fatty liver disease, improves hepatic steatosis in hamsters fed a high-fat diet.

    PubMed

    Shi, Huijie; Wang, Qingchun; Yang, Liu; Xie, Shouxia; Zhu, Haibo

    2017-09-01

    Nonalcoholic fatty liver disease (NAFLD), the most common chronic liver disease in humans, is characterized by the accumulation of triacylglycerols (TGs) in hepatocytes. We tested whether 2',3',5'-tri-acetyl-N6-(3-hydroxylaniline) adenosine (IMM-H007) can eliminate hepatic steatosis in hamsters fed a high-fat diet (HFD), as a model of NAFLD. Compared with HFD-only controls, IMM-H007 treatment significantly lowered serum levels of TG, total cholesterol, and free fatty acids (FFAs) in hamsters fed the HFD, with a prominent decrease in levels of serum transaminases and fasting insulin, without affecting fasting glucose levels. Moreover, 1 H-MRI and histopathological analyses revealed that hepatic lipid accumulation and fibrosis were improved by IMM-H007 treatment. These changes were accompanied by improvement of insulin resistance and oxidative stress, and attenuation of inflammation. IMM-H007 reduced expression of proteins involved in uptake of hepatic fatty acids and lipogenesis, and increased very low density lipoprotein secretion and expression of proteins responsible for fatty acid oxidation and autophagy. In studies in vivo , IMM-H007 inhibited fatty acid import into hepatocytes and liver lipogenesis, and concomitantly stimulated fatty acid oxidation, autophagy, and export of hepatic lipids. These data suggest that IMM-H007 resolves hepatic steatosis in HFD-fed hamsters by the regulation of lipid metabolism. Thus, IMM-H007 has therapeutic potential for NAFLD.

  4. Efficacy of Topical Alpha Ointment (Containing Natural Henna) Compared to Topical Hydrocortisone (1%) in the Healing of Radiation-Induced Dermatitis in Patients with Breast Cancer: A Randomized Controlled Clinical Trial

    PubMed Central

    Ansari, Mansour; Dehsara, Farzin; Mosalaei, Ahmad; Omidvari, Shapour; Ahmadloo, Niloofar; Mohammadianpanah, Mohammad

    2013-01-01

    Background: This two-arm, randomized clinical study aimed to compare efficacy between topical Alpha ointment and topical hydrocortisone cream (1%) in the healing of radiation-induced dermatitis in breast cancer patients. Methods: The inclusion criteria comprised newly pathologically proven, locally advanced breast cancer (treated with modified radical mastectomy followed by sequential adjuvant treatments, including chest wall radiotherapy [45-50.4 Gy]) and grade 2 and/or 3 chest wall dermatitis. The exclusion criteria were comprised of any underlying disease or medications interfering with the wound healing process, previous history of chest wall radiotherapy, and concurrent use of chemotherapy. Sixty eligible patients were randomly assigned to use either topical Alpha ointment (study arm, n=30) or topical hydrocortisone cream (1%) (control arm, n=30) immediately after receiving a total dose of 45-50 Gy chest wall radiotherapy. Results: The mean radiation dose was 49.1 Gy in the control arm and 48.8 Gy in the study arm. The mean dermatitis area was 13.54 cm2 in the control arm and 17.02 cm2 in the study arm. Topical Alpha ointment was more effective on the healing of radiation-induced dermatitis than was topical hydrocortisone cream (1%) (P=0.001). This effect was significant in the second week (P=0.007). In addition, Alpha ointment decreased the patients’ complaints such as pain (P<0.001), pruritus (P=0.009), and discharge (P=0.010) effectively and meaningfully. Conclusion: Topical Alpha ointment was more effective on the healing of radiation-induced dermatitis than was topical hydrocortisone cream (1%) in our patients with breast cancer. Trial Registration Numbers: IRCT201206099979N1, ACTRN12612000837820 PMID:24293782

  5. Efficacy of topical alpha ointment (containing natural henna) compared to topical hydrocortisone (1%) in the healing of radiation-induced dermatitis in patients with breast cancer: a randomized controlled clinical trial.

    PubMed

    Ansari, Mansour; Farzin, Dehsara; Mosalaei, Ahmad; Omidvari, Shapour; Ahmadloo, Niloofar; Mohammadianpanah, Mohammad

    2013-12-01

    This two-arm, randomized clinical study aimed to compare efficacy between topical Alpha ointment and topical hydrocortisone cream (1%) in the healing of radiation-induced dermatitis in breast cancer patients. The inclusion criteria comprised newly pathologically proven, locally advanced breast cancer (treated with modified radical mastectomy followed by sequential adjuvant treatments, including chest wall radiotherapy [45-50.4 Gy]) and grade 2 and/or 3 chest wall dermatitis. The exclusion criteria were comprised of any underlying disease or medications interfering with the wound healing process, previous history of chest wall radiotherapy, and concurrent use of chemotherapy. Sixty eligible patients were randomly assigned to use either topical Alpha ointment (study arm, n=30) or topical hydrocortisone cream (1%) (control arm, n=30) immediately after receiving a total dose of 45-50 Gy chest wall radiotherapy. The mean radiation dose was 49.1 Gy in the control arm and 48.8 Gy in the study arm. The mean dermatitis area was 13.54 cm(2) in the control arm and 17.02 cm(2) in the study arm. Topical Alpha ointment was more effective on the healing of radiation-induced dermatitis than was topical hydrocortisone cream (1%) (P=0.001). This effect was significant in the second week (P=0.007). In addition, Alpha ointment decreased the patients' complaints such as pain (P<0.001), pruritus (P=0.009), and discharge (P=0.010) effectively and meaningfully. Topical Alpha ointment was more effective on the healing of radiation-induced dermatitis than was topical hydrocortisone cream (1%) in our patients with breast cancer. IRCT201206099979N1, ACTRN12612000837820.

  6. Canine periodontal disease control using a clindamycin hydrochloride gel.

    PubMed

    Johnston, Thomas P; Mondal, Pravakar; Pal, Dhananjay; MacGee, Scott; Stromberg, Arnold J; Alur, Hemant

    2011-01-01

    Stabilizing or reducing periodontal pocket depth can have a positive influence on the retention of teeth in dogs. A topical 2% clindamycin hydrochloride gel (CHgel) was evaluated for the treatment of periodontal disease in dogs. The CHgel formulation provides for the sustained erosion of the matrix, but also flows into the periodontal pocket as a viscous liquid, and then rapidly forms a gel that has mucoadhesive properties and also may function as a physical barrier to the introduction of bacteria. A professional teeth cleaning procedure including scaling and root planing was done in dogs with one group receiving CHgel following treatment. Periodontal health was determined before and after the procedure including measurement of periodontal pocket depth, gingival index, gingival bleeding sites, and number of suppurating sites. There was a statistically significant decrease in periodontal pocket depth (19%), gingival index (16%), and the number of bleeding sites (64%) at 90-days in dogs receiving CHgel. Additionally, the number of suppurating sites was lower (93%) at 90-days for the group receiving CHgel. The addition of CHgel effectively controlled the bacterial burden (e.g, Fusobacterium nucleatum) at both day 14 and 90. Gingival cells in culture were shown to rapidly incorporate clindamycin and attain saturation in approximately 20-minutes. In summary, a professional teeth cleaning procedure including root planning and the addition of CHgel improves the gingival index and reduces periodontal pocket depth.

  7. 46 CFR 164.007-4 - Testing procedure.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ...: SPECIFICATIONS AND APPROVAL MATERIALS Structural Insulations § 164.007-4 Testing procedure. (a) Tests. All tests.... Measurements of dimensions of fibrous insulations shall be made to the nearest 1.5 mm. (1/16″) on a nominal 30... heat the bottle and sample at 105° ±5 °C. (221° ±9 °F.) for 4 hours, insert the stopper, cool and weigh...

  8. 46 CFR 164.007-4 - Testing procedure.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ...: SPECIFICATIONS AND APPROVAL MATERIALS Structural Insulations § 164.007-4 Testing procedure. (a) Tests. All tests.... Measurements of dimensions of fibrous insulations shall be made to the nearest 1.5 mm. (1/16″) on a nominal 30... heat the bottle and sample at 105° ±5 °C. (221° ±9 °F.) for 4 hours, insert the stopper, cool and weigh...

  9. 46 CFR 164.007-4 - Testing procedure.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ...: SPECIFICATIONS AND APPROVAL MATERIALS Structural Insulations § 164.007-4 Testing procedure. (a) Tests. All tests.... Measurements of dimensions of fibrous insulations shall be made to the nearest 1.5 mm. (1/16″) on a nominal 30... heat the bottle and sample at 105° ±5 °C. (221° ±9 °F.) for 4 hours, insert the stopper, cool and weigh...

  10. 46 CFR 164.007-4 - Testing procedure.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ...: SPECIFICATIONS AND APPROVAL MATERIALS Structural Insulations § 164.007-4 Testing procedure. (a) Tests. All tests.... Measurements of dimensions of fibrous insulations shall be made to the nearest 1.5 mm. (1/16″) on a nominal 30... heat the bottle and sample at 105° ±5 °C. (221° ±9 °F.) for 4 hours, insert the stopper, cool and weigh...

  11. 46 CFR 164.007-4 - Testing procedure.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ...: SPECIFICATIONS AND APPROVAL MATERIALS Structural Insulations § 164.007-4 Testing procedure. (a) Tests. All tests.... Measurements of dimensions of fibrous insulations shall be made to the nearest 1.5 mm. (1/16″) on a nominal 30... heat the bottle and sample at 105° ±5 °C. (221° ±9 °F.) for 4 hours, insert the stopper, cool and weigh...

  12. X-ray flux of the Narrow-Line Seyfert 1 galaxy WPVS 007 during a high UV flux state

    NASA Astrophysics Data System (ADS)

    Grupe, Dirk

    2016-09-01

    We request a short, 10ks, observation with Chandra ACIS-S of the highly X-ray variable Narrow Line Seyfert 1 Galaxy WPVS 007 quasi-simultaneously with HST between March 13 and 26. WPVS 007 is one of the most unusual AGN showing strong variabilty in broad absorption lines - a feature that is only seen in high-luminous quasars. We have monitored WPVS 007 since October 2005 with Swift, but we can typically not detect it in X-rays. Our last observation of WPVS 007 by Chandra in March 2015 when it was fount to be in an extremely low UV flux state (Leighgly et al. 2015) found it at a level of 8e-4 counts/s in ACIS-s corresponding to a flux in the 0.3-10 keV band of 1e-17 W/m2. Merging all Swift observaton since then (66ks) results in an 3sigma ul of 1.4e-17 W/m2. Obtaining a Chandra observation close to the HST observation will provide us with a crucial flux measurement that will allow us to determine the intrinsic luminosity of the AGN. Note, WPVS007 is currently at a bright UV state.

  13. Effect of a 2% topical chamomile application for treating burning mouth syndrome: a controlled clinical trial.

    PubMed

    Valenzuela, Sara; Pons-Fuster, Alvaro; López-Jornet, Pia

    2016-08-01

    The treatments for burning mouth syndrome (BMS) proposed to date have been varied but have only achieved limited efficacy. Chamomile has analgesic and anti-inflammatory properties. The aim of this study was to evaluate the efficacy of topical applications of 2% chamomile gel in comparison with a placebo for the treatment of BMS. The study was designed as a prospective randomized placebo-controlled double-blind monocentric study. A total of 62 patients with idiopathic BMS were divided into two groups: Group A received applications of a 2% chamomile gel, and Group B (placebo) were administered a placebo; both treatments were applied twice daily for 1 month. Three variables were evaluated at base line, 15 and 30 days: pain (assessed using a visual analogue scale [VAS]), xerostomia severity (Xerostomia Inventory), and oral quality of life (assessed by means of the Oral Health Impact Profile-14). A total of 57 patients completed the study. Pain, xerostomia, and quality of life underwent improvements with statistical significance at 15 and 30 days in both groups (P < 0.001). But when the two groups were compared, differences in VAS pain were not significant (P = 0.847), nor were xerostomia severity (P = 0.536), or oral quality of life (P = 0.076). The chamomile gel product was well tolerated. As treatment with chamomile and the placebo produced similar outcomes, the efficacy of 2% chamomile gel for treating BMS appears questionable. However, further studies with larger patient samples are needed to confirm this. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  14. STS113-S-007

    NASA Image and Video Library

    2002-11-23

    STS113-S-007 (23 November 2002) --- Against a black night sky, the Space Shuttle Endeavour heads toward Earth orbit and a scheduled link-up with the International Space Station (ISS). Liftoff from the Kennedy Space Center's Launch Complex 39 occurred at 7:49:47 p.m. (EST), November 23, 2002. The launch is the 19th for Endeavour, and the 112th flight in the Shuttle program. Mission STS-113 is the 16th assembly flight to the International Space Station, carrying another structure for the Station, the P1 integrated truss. Crewmembers onboard were astronauts James D. Wetherbee, commander; Paul S. Lockhart, pilot, along with astronauts Michael E. Lopez-Alegria and John B. Herrington, both mission specialists. Also onboard were the Expedition 6 crewmembers--astronauts Kenneth D. Bowersox and Donald R. Pettit, along with cosmonaut Nikolai M. Budarin--who went on to replace Expedition 5 aboard the Station.

  15. A scanning electron microscopy study of diseased root surfaces conditioned with EDTA gel plus Cetavlon after scaling and root planing.

    PubMed

    Martins Júnior, Walter; De Rossi, Andiara; Samih Georges Abi Rached, Ricardo; Rossi, Marcos Antonio

    2011-01-01

    In the present investigation, a scanning electron microscopy analysis was performed to evaluate the effects of the topical application of ethylenediaminetetraacetic acid (EDTA) gel associated with Cetavlon (EDTAC) in removing the smear layer and exposing collagen fibers following root surface instrumentation. Twenty-eight teeth from adult humans, single rooted and scheduled for extraction due to periodontal reasons, were selected. Each tooth was submitted to manual (scaling and root planing) instrumentation alone or combined with ultrasonic instruments, with or without etching using a 24% EDTAC gel. Following extraction, specimens were processed and examined under a scanning electron microscope. A comparative morphological semi-quantitative analysis was performed; the intensity of the smear layer and the decalcification of cementum and dentinal surfaces were graded in 12 sets using an arbitrary scale ranging from 1 (area covered by a smear layer) to 4 (no smear layer). Root debridement with hand instruments alone or combined with ultrasonic instruments resulted in a similar smear layer covering the root surfaces. The smear layer was successfully removed from the surfaces treated with EDTAC, which exhibited numerous exposed dentinal tubules and collagen fibers. This study supports the hypothesis that manual instrumentation alone or instrumentation combined with ultrasonic instrumentation is unable to remove the smear layer, whereas the subsequent topical application of EDTAC gel effectively removes the smear layer, uncovers dentinal openings and exposes collagen fibers.

  16. [Impact of topical application of autologous platelet-rich gel on medical expenditure and length of stay in hospitals in diabetic patients with refractory cutaneous ulcers].

    PubMed

    Li, Lan; Wang, Chun; Wang, Yan; He, Li-Ping; Yang, Yan-Zhi; Chen, Li-Hong; Chen, Da-Wei; Li, Xiu-Jun; Ran, Xing-Wu

    2012-09-01

    To evaluate the potential financial benefit of topical application of autologous platelet-rich gel (APG) in treating diabetic refractory cutaneous ulcers. A single-center prospective randomized controlled trial was undertaken, with 117 patients with proven diabetic refractory cutaneous ulcers participating in the study. The patients who gave informed consents were randomly assigned into standard care group (n = 58) or standard care plus topical application of APG treatment group (n = 59). The outcome of healing and the medical expenditur and length of stay in the patients were compared between the two groups. The APG-treated group had better healing outcomes than the standard-treated group. The APG-treated group had 84.750 (50/59) complete healing and 98.31% improvement, higher than the 68.97% (40/58) and 75.86%, respectively, in the standard-treated group (P = 0.026). The median length for healing in the APG-treated patients was 36 days, shorter than the 45 days in the standard-treated patients (P = 0.012). The total medical expenditure and length of stay in hospitals were not significantly different between APG-treated patients [yen 38223 (23070-57398); 57 (41-94) days] and standard-treated patients [yen 35070 (24436-53649); 58 (31.75-58.50) days) (P = 0.455 and 0.301 respectively). Spendings on items such as medicine, artificial treatment, materials, interventional operation, surgical procedures, laboratory tests and other auxiliary examination, accommodations, meals, nursing care and debridement and dressing change were similar between the two groups (P > 0.05). There is an advantage for the topical application of APG on diabetic refractory cutaneous ulcers in terms of the healing outcomes. APG is a cost-effective choice for patients with diabetic refractory cutaneous ulcers.

  17. Investigation of Preparation and Mechanisms of a Dispersed Particle Gel Formed from a Polymer Gel at Room Temperature

    PubMed Central

    Zhao, Guang; Dai, Caili; Zhao, Mingwei; You, Qing; Chen, Ang

    2013-01-01

    A dispersed particle gel (DPG) was successfully prepared from a polymer gel at room temperature. The polymer gel system, morphology, viscosity changes, size distribution, and zeta potential of DPG particles were investigated. The results showed that zirconium gel systems with different strengths can be cross-linked within 2.5 h at low temperature. Scanning electron microscopy (SEM), transmission electron microscopy (TEM), and atomic force microscopy (AFM) results showed that the particles were polygonal particles with nano-size distribution. According to the viscosity changes, the whole preparation process can be divided into two major stages: the bulk gel cross-linking reaction period and the DPG particle preparation period. A polymer gel with a 3-dimensional network was formed in the bulk gel cross-linking reaction period whereas shearing force and frictional force were the main driving forces for the preparation of DPG particles, and thus affected the morphology of DPG particles. High shearing force and frictional force reduced the particle size distribution, and then decreased the zeta potential (absolute value). The whole preparation process could be completed within 3 h at room temperature. It could be an efficient and energy-saving technology for preparation of DPG particles. PMID:24324817

  18. STS117-S-007

    NASA Image and Video Library

    2007-06-08

    STS117-S-007 (8 June 2007) --- After suiting up, the STS-117 crewmembers exit the Operations and Checkout Building to board the Astrovan, which will take them to launch pad 39A at Kennedy Space Center. On the right (front to back) are astronauts Rick Sturckow, commander; Steven Swanson, Clayton Anderson and Jim Reilly, all mission specialists. On the left (front to back) are astronauts Lee Archambault, pilot; Patrick Forrester and John "Danny" Olivas, both mission specialists. Anderson will join Expedition 15 in progress to serve as a flight engineer aboard the International Space Station. Atlantis will link up with the International Space Station on Sunday, June 10, to begin a joint mission that will increase the complex's power generation capability. Using the shuttle and station robotic arms and conducting three scheduled spacewalks, the astronauts will install another set of giant solar array wings on the station and retract another array, preparing it for a future move.

  19. Efficacy of topical chamomile management vs. placebo in patients with oral lichen planus: a randomized double-blind study.

    PubMed

    Lopez Jornet, P; Aznar-Cayuela, C

    2016-10-01

    The purpose of this study was to compare the clinical therapeutic efficacy of topical applications of chamomile vs. a placebo for treating oral lichen planus (OLP). This double-blind study, randomly divided 60 patients with OLP into two groups, 30 treated with 2% Chamaemelum nobile gel (0.5 mL/3 times a day) and 30 treated with a placebo (Trial Registration NCT02421770). A visual analogue scale was used to rate pain, itching and burning sensation, and Thongprasom Index, the Oral Health Impact Profile 14 (OHIP-14) and the Hospital Anxiety-Depression Scale. Patients were evaluated at baseline and after 4 weeks of treatment. Patients treated with chamomile showed significant improvements after 4 weeks for pain (P < 0.001), burning sensation (P < 0.001), itching (P = 0.011), OHIP-14 (P < 0.001) and Thongprasom index (P = 0.001); 92% of patients treated with chamomile showed a partial or total response, while only five subjects (17%) in the placebo group showed any improvement. The topical application of 2% chamomile gel is an effective treatment for OLP. © 2016 European Academy of Dermatology and Venereology.

  20. Effectiveness of silica based sol-gel microencapsulation method for odorants and flavors leading to sustainable environment

    PubMed Central

    Ashraf, Muhammad Aqeel; Khan, Aysha Masood; Ahmad, Mushtaq; Sarfraz, Maliha

    2015-01-01

    Microencapsulation has become a hot topic in chemical research. Technology mainly used for control release and protection purposes. The sol-gel micro encapsulation approach for fragrance and aroma in porous silica-based materials leads to sustainable odorant and flavored materials with novel and unique beneficial properties. Sol-gel encapsulation of silica based micro particles considered economically cheap as capital investment in manufacturing is very low and environmentally friendly. Amorphous sol-gel SiO2 is non-toxic and safe, whereas the sol-gel entrapment of delicate chemicals in its inner pores results in pronounced chemical and physical stabilization of the entrapped active agents, thereby broadening the practical utilization of chemically unstable essential oils (EOs). Reviewing progress in the fabrication of diverse odorant and flavored sol-gels, shows us how different synthetic strategies are appropriate for practical application with important health and environmental benefits. PMID:26322304

  1. Actuator device utilizing a conductive polymer gel

    DOEpatents

    Chinn, Douglas A.; Irvin, David J.

    2004-02-03

    A valve actuator based on a conductive polymer gel is disclosed. A nonconductive housing is provided having two separate chambers separated by a porous frit. The conductive polymer is held in one chamber and an electrolyte solution, used as a source of charged ions, is held in the second chamber. The ends of the housing a sealed with a flexible elastomer. The polymer gel is further provide with electrodes with which to apply an electrical potential across the gel in order to initiate an oxidation reaction which in turn drives anions across the porous frit and into the polymer gel, swelling the volume of the gel and simultaneously contracting the volume of the electrolyte solution. Because the two end chambers are sealed the flexible elastomer expands or contracts with the chamber volume change. By manipulating the potential across the gel the motion of the elastomer can be controlled to act as a "gate" to open or close a fluid channel and thereby control flow through that channel.

  2. Draft genome sequence of marine Streptomyces sp. strain W007, which produces angucyclinone antibiotics with a benz[a]anthracene skeleton.

    PubMed

    Qin, Song; Zhang, Hongyu; Li, Fuchao; Zhu, Benwei; Zheng, Huajun

    2012-03-01

    A series of angucyclinone antibiotics have been isolated from marine Streptomyces sp. strain W007 and identified. Here, a draft genome sequence of Streptomyces sp. W007 is presented. The genome contains an intact biosynthetic gene cluster for angucyclinone antibiotics, which provides insight into the combinatorial biosynthesis of angucyclinone antibiotics produced by marine streptomycetes.

  3. Antimicrobial efficacy of oral topical agents on microorganisms associated with radiated head and neck cancer patients: an in vitro study.

    PubMed

    Bidra, Avinash S; Tarrand, Jeffery J; Roberts, Dianna B; Rolston, Kenneth V; Chambers, Mark S

    2011-04-01

    A variety of oral topical agents have been used for prevention and management of radiotherapy-induced adverse effects. The antimicrobial nature of some of the commonly used agents is unknown. The purpose of this study was to evaluate antimicrobial efficacies of various oral topical agents on common microorganisms associated with radiated head and neck cancer patients. Seven commonly used topical oral agents-0.12% chlorhexidine with alcohol, 0.12% chlorhexidine without alcohol, baking soda-salt rinse, 0.4% stannous fluoride gel, 0.63% stannous fluoride rinse, calcium phosphate mouthrinse, and acemannan hydrogel (aloe vera) rinse-were evaluated in vitro for their antimicrobial efficacies against four common microorganisms. A combination of baking soda-salt rinse and 0.4% stannous fluoride gel was evaluated as the eighth agent. The microorganisms used were Staphylococcus aureus, group B Streptococcus, Escherichia coli, and Candida albicans. An ELISA reader was used to measure the turbidity of microbial culture wells and optical density (OD) values for each of the 960 wells recorded. Mean OD values were rank ordered based on their turbidity. One-way ANOVA with Tukey HSD post hoc analysis was used to study differences in OD values (P < .05). Mean OD values classified for topical agents from lowest to highest were chlorhexidine with alcohol, chlorhexidine without alcohol, baking soda- salt, calcium phosphate rinse, and the combination of baking soda-salt and stannous fluoride gel. Mean OD values classified for microorganisms from lowest to highest were Escherichia coli, Staphylococcus aureus, group B Streptococcus, and Candida albicans. A significant difference among the antimicrobial efficacies of topical agents was evident for each of four microorganisms (P < .05). There was also a significant difference among the antimicrobial efficacies of the same topical agent on the four microorganisms tested (P < .05).

  4. Sol-Gel Glasses

    NASA Technical Reports Server (NTRS)

    Mukherjee, S. P.

    1985-01-01

    Multicomponent homogeneous, ultrapure noncrystalline gels/gel derived glasses are promising batch materials for the containerless glass melting experiments in microgravity. Hence, ultrapure, homogeneous gel precursors could be used to: (1) investigate the effect of the container induced nucleation on the glass forming ability of marginally glass forming compositions; and (2) investigate the influence of gravity on the phase separation and coarsening behavior of gel derived glasses in the liquid-liquid immiscibility zone of the nonsilicate systems having a high density phase. The structure and crystallization behavior of gels in the SiO2-GeO2 as a function of gel chemistry and thermal treatment were investigated. As are the chemical principles involved in the distribution of a second network former in silica gel matrix being investigated. The procedures for synthesizing noncrystalline gels/gel-monoliths in the SiO2-GeO2, GeO2-PbO systems were developed. Preliminary investigations on the levitation and thermal treatment of germania silicate gel-monoliths in the Pressure Facility Acoustic Levitator were done.

  5. Homogeneity of gels and gel-derived glasses

    NASA Technical Reports Server (NTRS)

    Mukherjee, S. P.

    1984-01-01

    The significance and implications of gel preparation procedures in controlling the homogeneity of multicomponent oxide gels are discussed. The role of physicochemical factors such as the structure and chemical reactivities of alkoxides, the formation of double-metal alkoxides, and the nature of solvent(s) are critically analyzed in the context of homogeneity of gels during gelation. Three procedures for preparing gels in the SiO2-B2O3-Na2O system are examined in the context of cation distribution. Light scattering results for glasses in the SiO2-B2O3-Na2O system prepared by both the gel technique and the conventional technique are examined.

  6. 46 CFR 159.007-3 - Production inspections and tests: Independent laboratory's procedures.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 46 Shipping 6 2011-10-01 2011-10-01 false Production inspections and tests: Independent laboratory's procedures. 159.007-3 Section 159.007-3 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) EQUIPMENT, CONSTRUCTION, AND MATERIALS: SPECIFICATIONS AND APPROVAL APPROVAL OF EQUIPMENT AND MATERIALS Production Inspection and Tests of...

  7. 46 CFR 159.007-3 - Production inspections and tests: Independent laboratory's procedures.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 46 Shipping 6 2010-10-01 2010-10-01 false Production inspections and tests: Independent laboratory's procedures. 159.007-3 Section 159.007-3 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) EQUIPMENT, CONSTRUCTION, AND MATERIALS: SPECIFICATIONS AND APPROVAL APPROVAL OF EQUIPMENT AND MATERIALS Production Inspection and Tests of...

  8. Acceptability of a transdermal gel-based male hormonal contraceptive in a randomized controlled trial☆, ☆☆, ★

    PubMed Central

    Roth, Mara Y.; Shih, Grace; Ilani, Niloufar; Wang, Christina; Page, Stephanie T.; Bremner, William J.; Swerdloff, Ronald S.; Sitruk-Ware, Regine; Blithe, Diana L.; Amory, John K.

    2014-01-01

    Objective Fifty percent of pregnancies in the United States are unintended despite numerous contraceptive methods available to women. The only male contraceptive methods, vasectomy and condoms, are used by 10% and 16% of couples, respectively. Prior studies have shown efficacy of male hormonal contraceptives in development, but few have evaluated patient acceptability and potential use if commercially available. The objective of this study is to determine if a transdermal gel-based male hormonal contraceptive regimen, containing testosterone and Nestorone® gels, would be acceptable to study participants as a primary contraceptive method. Study Design As part of a three-arm, 6-month, double-blind, randomized controlled trial of testosterone and nestorone gels at two academic medical centers, subjects completed a questionnaire to assess the acceptability of the regimen. Of the 99 men randomized, 79 provided data for analysis. Results Overall, 56% (44/79) of men were satisfied or extremely satisfied with this gel-based method of contraception, and 51% (40/79) reported that they would recommend this method to others. One third of subjects (26/79) reported that they would use this as their primary method of contraception if it were commercially available today. However, men with concerns about sexually transmitted disease were significantly less satisfied than men without such concerns (p=0.03). Conclusions A majority of the men who volunteered to participate in this trial of an experimental male hormonal contraceptive were satisfied with this transdermal male hormonal contraceptive. If commercially available, a combination of topical nesterone and testosterone gels could provide a reversible, effective method of contraception that is appealing to men. Implications A substantial portion of men report they would use this transdermal male contraceptive regimen if commercially available. This method would provide a novel, reversible method of contraception for men, whose

  9. Dry Gel Containing Optimized Felodipine-Loaded Transferosomes: a Promising Transdermal Delivery System to Enhance Drug Bioavailability.

    PubMed

    Kassem, Mohammed Ali; Aboul-Einien, Mona Hassan; El Taweel, Mai Magdy

    2018-04-30

    Felodipine has a very low bioavailability due to first-pass metabolism. The aim of this study was to enhance its bioavailability by transdermal application. Felodipine-loaded transferosomes were prepared by thin-film hydration using different formulation variables. An optimized formula was designed using statistical experimental design. The independent variables were the used edge activator, its molar ratio to phosphatidylcholine, and presence or absence of cholesterol. The responses were entrapment efficiency of transferosomes, their size, polydispersity index, zeta potential, and percent drug released after 8 h. The optimized formula was subjected to differential scanning calorimetry studies and its stability on storage at 4°C for 6 months was estimated. This formula was improved by incorporation of different permeation enhancers where ex vivo drug flux through mice skin was estimated and the best improved formula was formulated in a gel and lyophilized. The prepared gel was subjected to in vivo study using Plendil® tablets as a reference. According to the calculated desirability, the optimized transferosome formula was that containing sodium deoxycholate as edge activator at 5:1 M ratio to phosphatidylcholine and no cholesterol. The thermograms of this formula indicated the incorporation of felodipine inside the prepared vesicles. None of the tested parameters differed significantly on storage. The lyophilized gel of labrasol-containing formula was chosen for in vivo study. The relative bioavailability of felodipine from the designed gel was 1.7. In conclusion, topically applied lyophilized gel containing felodipine-loaded transferosomes is a promising transdermal delivery system to enhance its bioavailability.

  10. A comparative study of the effects of topical application of Aloe vera, thyroid hormone and silver sulfadiazine on skin wounds in Wistar rats

    PubMed Central

    Norouzian, Mohsen; Zarein-Dolab, Saeed; Dadpay, Masoomeh; Gazor, Roohollah

    2012-01-01

    Many research studies report the healing effects of Aloe Vera, thyroid hormone cream and silver sulfadiazine. However, the effects of these therapeutic agents are not well understood and have not been compared in one study. This study aimed at investigating the effects of topical application of an Aloe vera gel, a thyroid hormone cream and a silver sulfadiazine cream on the healing of skin wounds surgically induced in Wistar rats for determining the treatment of choice. In a randomized controlled trial, twelve male rats, aged 120 days and with a mean weight of 250 to 300 g, were divided randomly into 5 groups based on drug treatments: Aloe vera gel (AV), thyroid hormone cream (TC), silver sulfadiazine 1% (S), vehicle (V) and control. To evaluate the efficacy of each treatment technique, a biomechanical approach was used to assess tensile stress after 14 days of treatment. Tensile stress was significantly improved in the Aloe vera gel group as compared with the other four groups (P≤0.05). While the other treatment options resulted in better healing than the control group, this difference was not significant. We conclude that Aloe vera topical application accelerated the healing process more than thyroid hormone, silver sulfadiazine and vehicle in surgically induced incisions in rats. PMID:22474470

  11. A novel transdermal nanoethosomal gel of betahistine dihydrochloride for weight gain control: in-vitro and in-vivo characterization

    PubMed Central

    El-Menshawe, Shahira F; Ali, Adel Ahmed; Halawa, Abdelkhalk Ali; Srag El-Din, Ahmed SG

    2017-01-01

    Background Betahistine dihydrochloride (BDH) is a histamine analog used to control weight gain, with short elimination half-life and gastric irritation as side effects. Objective The aim of the current investigation is to formulate and optimize a topical BDH ethosomal gel for weight gain control. Materials and methods Box–Behnken design was applied to study the effect of independent variables: phosphatidylcholine (PC), propylene glycol (PG), and ethanol on vesicle size; entrapment efficiency; % drug release; and flux. The morphology and zeta potential of the optimized formulation were evaluated. The % drug release, flux, and pharmacodynamics of the optimized formulation gel were studied. Results The size and entrapment efficiency percent had a direct positive relationship with the concentration of PC and negative relationship with ethanol and PG. The % drug release and flux decreased with increasing PC and PG, while ethanol enhanced both responses. Regression modeling indicated a good correlation between dependent and independent variables, where F16 was chosen as the optimized formulation. F16 showed well-defined spherical vesicles and zeta potential of −24 mV, and % release from the gel exceeded 99.5% over 16 h with the flux of 0.28 mg/cm2/h. Food intake and weight gain of rats were significantly decreased after transdermal application of the BDH ethosomal gel when compared with control, placebo, and BDH gel. The histopathological findings proved the absence of inflammation and decrease in adipose tissue. Conclusion Results obtained showed a significant, sustained transdermal absorption of BDH ethosomal gel and, consequently, a decrease in food intake and weight gain. PMID:29238164

  12. 46 CFR 159.007-5 - Production inspections and tests: Application for acceptance.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 46 Shipping 6 2010-10-01 2010-10-01 false Production inspections and tests: Application for acceptance. 159.007-5 Section 159.007-5 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) EQUIPMENT, CONSTRUCTION, AND MATERIALS: SPECIFICATIONS AND APPROVAL APPROVAL OF EQUIPMENT AND MATERIALS Production Inspection and Tests of Approved...

  13. 46 CFR 159.007-5 - Production inspections and tests: Application for acceptance.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 46 Shipping 6 2011-10-01 2011-10-01 false Production inspections and tests: Application for acceptance. 159.007-5 Section 159.007-5 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) EQUIPMENT, CONSTRUCTION, AND MATERIALS: SPECIFICATIONS AND APPROVAL APPROVAL OF EQUIPMENT AND MATERIALS Production Inspection and Tests of Approved...

  14. Release and skin distribution of silicone-related compound(s) from a silicone gel sheet in vitro.

    PubMed

    Shigeki, S; Nobuoka, N; Murakami, T; Ikuta, Y

    1999-01-01

    The efficacy of topical silicone gel sheeting in prevention and/or reduction of keloids and hypertrophic scars is well recognized. In the present study, we reexamined the possible release of silicone-related compound(s) from a commercially available silicone gel sheet (Cica-Care, Smith and Nephew, Hull, England) in aqueous media in vitro. The silicone gel sheet was also applied on the excised skin surface to examine the possible distribution of silicone-related compounds into the skin in vitro. Silicone-related compounds were measured as silicon by an inductively coupled plasma-atomic emission spectrophotometer. When a piece of silicone gel sheet was placed in phosphate buffer solution (pH 3-9) at 37 degrees C for 7 days, the concentration of silicon in the medium increased with time, depending on the pH of the medium. This indicates that the released silicone-related compounds are water-soluble. When Cica-Care was applied on the surface of excised rat skin, human axilla skin and hypertrophic scars under hydrated conditions in vitro, silicon was detected in all skin samples. Greater distribution was observed in rat skin than in human axilla skin and hypertrophic scars. The release of silicone-related compounds from a silicone gel sheet (Cica-Care) and their distribution into the skin were demonstrated in vitro. Silicone-related compounds distributed into the skin may have pharmacological effects on the skin. Further investigation will be necessary to investigate in detail the action of silicone-related compounds on the proliferation of fibroblasts and excessive production of collagen.

  15. s48-e-007

    NASA Image and Video Library

    2013-01-15

    S48-E-007 (12 Sept 1991) --- Astronaut James F. Buchli, mission specialist, catches snack crackers as they float in the weightless environment of the earth-orbiting Discovery. This image was transmitted by the Electronic Still Camera, Development Test Objective (DTO) 648. The ESC is making its initial appearance on a Space Shuttle flight. Electronic still photography is a new technology that enables a camera to electronically capture and digitize an image with resolution approaching film quality. The digital image is stored on removable hard disks or small optical disks, and can be converted to a format suitable for downlink transmission or enhanced using image processing software. The Electronic Still Camera (ESC) was developed by the Man- Systems Division at the Johnson Space Center and is the first model in a planned evolutionary development leading to a family of high-resolution digital imaging devices. H. Don Yeates, JSC's Man-Systems Division, is program manager for the ESC. THIS IS A SECOND GENERATION PRINT MADE FROM AN ELECTRONICALLY PRODUCED NEGATIVE

  16. INGN 007, an oncolytic adenovirus vector, replicates in Syrian hamsters but not mice: comparison of biodistribution studies

    PubMed Central

    Ying, B; Toth, K; Spencer, JF; Meyer, J; Tollefson, AE; Patra, D; Dhar, D; Shashkova, EV; Kuppuswamy, M; Doronin, K; Thomas, MA; Zumstein, LA; Wold, WSM; Lichtenstein, DL

    2012-01-01

    Preclinical biodistribution studies with INGN 007, an oncolytic adenovirus (Ad) vector, supporting an early stage clinical trial were conducted in Syrian hamsters, which are permissive for Ad replication, and mice, which are a standard model for assessing toxicity and biodistribution of replication-defective (RD) Ad vectors. Vector dissemination and pharmacokinetics following intravenous administration were examined by real-time PCR in nine tissues and blood at five time points spanning 1 year. Select organs were also examined for the presence of infectious vector/virus. INGN 007 (VRX-007), wild-type Ad5 and AdCMVpA (an RD vector) were compared in the hamster model, whereas only INGN 007 was examined in mice. DNA of all vectors was widely disseminated early after injection, but decayed rapidly in most organs. In the hamster model, DNA of INGN 007 and Ad5 was more abundant than that of the RD vector AdCMVpA at early times after injection, but similar levels were seen later. An increased level of INGN 007 and Ad5 DNA but not AdCMVpA DNA in certain organs early after injection, and the presence of infectious INGN 007 and Ad5 in lung and liver samples at early times after injection, strongly suggests that replication of INGN 007 and Ad5 occurred in several Syrian hamster organs. There was no evidence of INGN 007 replication in mice. In addition to providing important information about INGN 007, the results underscore the utility of the Syrian hamster as a permissive immunocompetent model for Ad5 pathogenesis and oncolytic Ad vectors. PMID:19197322

  17. INGN 007, an oncolytic adenovirus vector, replicates in Syrian hamsters but not mice: comparison of biodistribution studies.

    PubMed

    Ying, B; Toth, K; Spencer, J F; Meyer, J; Tollefson, A E; Patra, D; Dhar, D; Shashkova, E V; Kuppuswamy, M; Doronin, K; Thomas, M A; Zumstein, L A; Wold, W S M; Lichtenstein, D L

    2009-08-01

    Preclinical biodistribution studies with INGN 007, an oncolytic adenovirus (Ad) vector, supporting an early stage clinical trial were conducted in Syrian hamsters, which are permissive for Ad replication, and mice, which are a standard model for assessing toxicity and biodistribution of replication-defective (RD) Ad vectors. Vector dissemination and pharmacokinetics following intravenous administration were examined by real-time PCR in nine tissues and blood at five time points spanning 1 year. Select organs were also examined for the presence of infectious vector/virus. INGN 007 (VRX-007), wild-type Ad5 and AdCMVpA (an RD vector) were compared in the hamster model, whereas only INGN 007 was examined in mice. DNA of all vectors was widely disseminated early after injection, but decayed rapidly in most organs. In the hamster model, DNA of INGN 007 and Ad5 was more abundant than that of the RD vector AdCMVpA at early times after injection, but similar levels were seen later. An increased level of INGN 007 and Ad5 DNA but not AdCMVpA DNA in certain organs early after injection, and the presence of infectious INGN 007 and Ad5 in lung and liver samples at early times after injection, strongly suggests that replication of INGN 007 and Ad5 occurred in several Syrian hamster organs. There was no evidence of INGN 007 replication in mice. In addition to providing important information about INGN 007, the results underscore the utility of the Syrian hamster as a permissive immunocompetent model for Ad5 pathogenesis and oncolytic Ad vectors.

  18. A multi-centre clinical evaluation of reactive oxygen topical wound gel in 114 wounds.

    PubMed

    Dryden, M; Dickinson, A; Brooks, J; Hudgell, L; Saeed, K; Cutting, K F

    2016-03-01

    This article reports the outcomes of the use of Surgihoney RO (SHRO), topical wound dressing in a multi-centre, international setting. The aims were to explore the clinical effects of SHRO, including a reduction in bacterial load and biofilm and improvement in healing in a variety of challenging non-healing and clinically infected wounds. This was a non-comparative evaluation, where both acute and chronic wounds with established delayed healing were treated with the dressing. Clinicians prospectively recorded wound improvement or deterioration, level of wound exudate, presence of pain, and presence of slough and necrosis. Analysis of this data provided information on clinical performance of the dressing. Semi-quantitative culture to assess bacterial bioburden was performed where possible. We recruited 104 patients, mean age 61 years old, with 114 wounds. The mean duration of wounds before treatment was 3.7 months and the mean duration of treatment was 25.7 days. During treatment 24 wounds (21%) healed and the remaining 90 (79%) wounds improved following application of the dressing. No deterioration in any wound was observed. A reduction in patient pain, level of wound exudate and in devitalised tissue were consistently reported. These positive improvements in wound progress were reflected in the wound cultures that showed a reduction in bacterial load in 39 out of the 40 swabs taken. There were two adverse events recorded: a stinging sensation following application of the dressing was experienced by 2 patients, and 2 elderly patients died of causes unrelated to the dressing or to the chronic wound. These patients' wounds and their response to SHRO have been included in the analysis. SHRO was well tolerated and shows great promise as an effective potent topical antimicrobial in the healing of challenging wounds. Matthew Dryden has become a shareholder in Matoke Holdings, the manufacturer of Surgihoney RO, since the completion of this study. Keith Cutting is a

  19. EFFICACY AND SAFETY OF A NEW TOPICAL TESTOSTERONE REPLACEMENT GEL THERAPY FOR THE TREATMENT OF MALE HYPOGONADISM.

    PubMed

    Cunningham, Glenn; Belkoff, Laurence; Brock, Gerald; Efros, Mitchell; Gittelman, Marc; Carrara, Dario; Neijber, Anders; Ando, Masakazu; Mitchel, Jules

    2017-05-01

    Testosterone replacement therapy is indicated for male hypogonadism. This study aimed to evaluate the efficacy and safety of testosterone gel 2% (Tgel) over 90 days. This phase 3, open-label, noncomparator study was conducted in adult hypogonadal men (2 consecutive fasting serum testosterone values <300 ng/dL and >86% subjects with symptoms consistent with testosterone deficiency). Subjects applied Tgel 23 mg/day (single pump-actuation using a hands-free cap applicator). The dose was uptitrated to 46 mg/day after 2 weeks if the 4-hour serum total testosterone level was <500 ng/dL. The dose could be further up- or downtitrated to 23, 46, and 69 mg on Days 21, 42, and 63. The primary endpoint included the percentage of subjects with average testosterone concentration (C ave (0-24) ) between 300 and 1,050 ng/dL on Day 90. Safety endpoints were adverse events (AEs), laboratory parameters, and vital signs. Of the 159 who enrolled, 139 men completed the study. Approximately three-quarters (76.1%) of subjects met C ave criteria on Day 90. Most AEs were mild to moderate. There were 5 serious AEs, and 1 (myocardial infarction) was judged as possibly related to Tgel. Confirmed excessive increases in prostate-specific antigen or hematocrit levels were rare. Tgel had a favorable local skin tolerability profile. Overall, 76% of subjects achieved C ave between 300 and 1,050 ng/dL with Tgel. Symptoms of testosterone deficiency improved with few safety concerns. AE = adverse event C ave(0-24) = average testosterone concentration CI = confidence interval C max = maximum concentration IIEF = International Index of Erectile Function MAF = Multidimensional Assessment of Fatigue PK = pharmacokinetic PSA = prostate-specific antigen SAE = serious adverse event SF-12 = Short Form 12 Health Survey Tgel = testosterone gel 2% T max = time to achieve maximum concentration TRT = testosterone replacement therapy.

  20. Topical photosan-mediated photodynamic therapy for DMBA-induced hamster buccal pouch early cancer lesions: an in vivo study

    NASA Astrophysics Data System (ADS)

    Hsu, Yih-Chih; Chang, Walter Hong-Shong; Chang, Junn-Liang; Liu, Kuang-Ting; Chiang, Chun-Pin; Liu, Chung-Ji; Chen, Chih-Ping

    2011-03-01

    Oral cancer has becomes the most prominent cancer disease in recent years in Taiwan. The reason is the betel nut chewing habit combing with smoking and alcohol-drinking lifestyle of people results in oral cancer becomes the fastest growth incident cancer amongst other major cancer diseases. In previous studies showed that photosan, haematoporphyrin derivative (HPD), has demonstrated effective PDT results on human head and neck disease studies. To avoid the systemic phototoxic effect of photosan, this study was designed to use a topical photosan-mediated PDT for treatment of DMBA-induced hamster buccal pouch cancerous lesions. DMBA was applied to one of the buccal pouches of hamsters thrice a week for 10 to 12 weeks. Cancerous lesions were induced and proven by histological examination. These DMBA-induced cancerous lesions were used for testing the efficacy of topical photosan-mediated PDT. Before PDT, fluorescence spectroscopy was used to determine when photosan reached its peak level in the lesional epithelial cells after topical application of photosan gel. We found that photosan reached its peak level in cancerous lesions about 13.5 min after topical application of photosan gel. The cancerous lesions in hamsters were then treated with topical photosan-mediated PDT (fluence rate: 600 mW/cm2; light exposure dose 200 J/cm2) using the portable Lumacare 635 nm fiber-guided light device. Visual examination demonstrated that topical photosan-mediated PDT was an applicable treatment modality for DMBA-induced hamster buccal pouch cancerous lesions.

  1. Drug-free gel containing ultra-deformable phospholipid vesicles (TDT 064) as topical therapy for the treatment of pain associated with osteoarthritis: a review of clinical efficacy and safety.

    PubMed

    Conaghan, Philip G; Bijlsma, Johannes W; Kneer, Werner; Wise, Elspeth; Kvien, Tore K; Rother, Matthias

    2014-04-01

    Many patients with osteoarthritis (OA) experience side effects with available systemic therapies, some of which can be life threatening. The widespread use of nonsteroidal anti-inflammatory drugs (NSAIDs), often without prescription, is concerning given their potential risks. New treatments for OA are therefore required. This review discusses evidence supporting the use of TDT 064, a drug-free, topical gel containing ultra-deformable phospholipid vesicles (Sequessome * vesicles), for OA-associated pain. Preclinical and clinical studies investigating TDT 064 in patients with OA-associated knee pain were identified in searches of PubMed and congress abstracts. The ultra-deformable phospholipid vesicles (sequessome vesicles) in TDT 064 pass through the skin intact to reach the synovial space within the joint. The mechanism of action is not yet certain, but the phospholipid-based structure of these ultra-deformable phospholipid vesicles, and the observation that they localize to the cartilage surface, support biolubrication as a possible mechanism of action of TDT 064. Data from randomized, phase III studies in OA knee pain in which TDT 064 was used as the drug-free vehicle control for IDEA-033 (ketoprofen in ultra-deformable phospholipid vesicles) demonstrate a marked and consistent response to TDT 064 in terms of pain, stiffness, and function. In a 12 week study of >1300 patients, the effects of TDT 064 on pain and function were statistically noninferior to those of oral celecoxib, and superior to oral placebo. TDT 064 was well tolerated in all studies, and adverse events were typically mild-to-moderate effects on the skin. Evidence from clinical studies supports the use of TDT 064 as a drug-free topical treatment for patients with OA. Further experience with TDT 064, particularly among patients with comorbidities or NSAID contraindications, will provide more information on its potential use.

  2. GelScape: a web-based server for interactively annotating, manipulating, comparing and archiving 1D and 2D gel images.

    PubMed

    Young, Nelson; Chang, Zhan; Wishart, David S

    2004-04-12

    GelScape is a web-based tool that permits facile, interactive annotation, comparison, manipulation and storage of protein gel images. It uses Java applet-servlet technology to allow rapid, remote image handling and image processing in a platform-independent manner. It supports many of the features found in commercial, stand-alone gel analysis software including spot annotation, spot integration, gel warping, image resizing, HTML image mapping, image overlaying as well as the storage of gel image and gel annotation data in compliance with Federated Gel Database requirements.

  3. Effect of rubbing on the in vitro skin permeation of diclofenac-diethylamine 1.16% gel.

    PubMed

    Hasler-Nguyen, Nathalie; Fotopoulos, Grigorios

    2012-06-21

    Rubbing a topical NSAID (non steroidal anti-inflammatory drug) on the skin may increase local drug permeation, affecting its distribution to the site of pain and inflammation. The present study evaluates this hypothesis, by assessing in vitro the effect on skin permeation of applying diclofenac-dieythylamine 1.16% gel with or without rubbing. A single dose of 5 mg/cm2 diclofenac-diethylamine 1.16% gel was applied on excised human skin mounted in Franz-type diffusion cells without or with rubbing for 45 s. Drug penetration into the skin layers was determined after 1 h using the tape stripping technique. In vitro cutaneous permeation into the receptor fluid of the diffusion chamber was measured up to 24 h. Skin electrical resistance was also recorded. Application of diclofenac-diethylamine 1.16% gel with rubbing resulted to a 5-fold higher flux of diclofenac through the skin than when applied without rubbing at 8 h (P = 0.04). Skin rubbing for 45 s decreased by 2-fold skin electrical resistance when compared to the standard application. Application of diclofenac-diethylamine 1.16% gel with rubbing tended to result in higher accumulation in the stripped skin vs. the superficial skin layers when applied without rubbing (P = 0.2). These results suggest that rubbing may alter the superficial skin layer resulting in a transient faster initial diffusion of topically applied diclofenac through the stratum corneum into the deeper skin layer of the dermis to the tissue target.

  4. Effect of rubbing on the in vitro skin permeation of diclofenac-diethylamine 1.16% gel

    PubMed Central

    2012-01-01

    Background Rubbing a topical NSAID (non steroidal anti-inflammatory drug) on the skin may increase local drug permeation, affecting its distribution to the site of pain and inflammation. The present study evaluates this hypothesis, by assessing in vitro the effect on skin permeation of applying diclofenac-dieythylamine 1.16% gel with or without rubbing. Methods A single dose of 5 mg/cm2 diclofenac-diethylamine 1.16% gel was applied on excised human skin mounted in Franz-type diffusion cells without or with rubbing for 45 s. Drug penetration into the skin layers was determined after 1 h using the tape stripping technique. In vitro cutaneous permeation into the receptor fluid of the diffusion chamber was measured up to 24 h. Skin electrical resistance was also recorded. Results Application of diclofenac-diethylamine 1.16% gel with rubbing resulted to a 5-fold higher flux of diclofenac through the skin than when applied without rubbing at 8 h (P = 0.04). Skin rubbing for 45 s decreased by 2-fold skin electrical resistance when compared to the standard application. Application of diclofenac-diethylamine 1.16% gel with rubbing tended to result in higher accumulation in the stripped skin vs. the superficial skin layers when applied without rubbing (P = 0.2). Conclusion These results suggest that rubbing may alter the superficial skin layer resulting in a transient faster initial diffusion of topically applied diclofenac through the stratum corneum into the deeper skin layer of the dermis to the tissue target. PMID:22720797

  5. The gel electrophoresis markup language (GelML) from the Proteomics Standards Initiative.

    PubMed

    Gibson, Frank; Hoogland, Christine; Martinez-Bartolomé, Salvador; Medina-Aunon, J Alberto; Albar, Juan Pablo; Babnigg, Gyorgy; Wipat, Anil; Hermjakob, Henning; Almeida, Jonas S; Stanislaus, Romesh; Paton, Norman W; Jones, Andrew R

    2010-09-01

    The Human Proteome Organisation's Proteomics Standards Initiative has developed the GelML (gel electrophoresis markup language) data exchange format for representing gel electrophoresis experiments performed in proteomics investigations. The format closely follows the reporting guidelines for gel electrophoresis, which are part of the Minimum Information About a Proteomics Experiment (MIAPE) set of modules. GelML supports the capture of metadata (such as experimental protocols) and data (such as gel images) resulting from gel electrophoresis so that laboratories can be compliant with the MIAPE Gel Electrophoresis guidelines, while allowing such data sets to be exchanged or downloaded from public repositories. The format is sufficiently flexible to capture data from a broad range of experimental processes, and complements other PSI formats for MS data and the results of protein and peptide identifications to capture entire gel-based proteome workflows. GelML has resulted from the open standardisation process of PSI consisting of both public consultation and anonymous review of the specifications.

  6. Does Topical Ozone Therapy Improve Patient Comfort After Surgical Removal of Impacted Mandibular Third Molar? A Randomized Controlled Trial.

    PubMed

    Sivalingam, Varun P; Panneerselvam, Elavenil; Raja, Krishnakumar V B; Gopi, Gayathri

    2017-01-01

    To assess the influence of topical ozone administration on patient comfort after third molar surgery. A single-blinded randomized controlled clinical trial was designed involving patients who required removal of bilateral impacted mandibular third molars. The predictor variable was the postoperative medication used after third molar surgery. Using the split-mouth design, the study group received topical ozone without postoperative systemic antibiotics, whereas the control group did not receive ozone but only systemic antibiotics. The 2 groups were prescribed analgesics for 2 days. The assessing surgeon was blinded to treatment assignment. The primary outcome variables were postoperative mouth opening, pain, and swelling. The secondary outcome variable was the number of analgesic doses required by each group on postoperative days 3 to 5. Data analysis involved descriptive statistics, paired t tests, and 2-way analysis of variance with repeated measures (P < .05). SPSS 20.0 was used for data analysis. The study sample included 33 patients (n = 33 in each group). The study group showed statistically relevant decreases in postoperative pain, swelling, and trismus. Further, the number of analgesics required was smaller than in the control group. No adverse effects of ozone gel were observed in any patient. Ozone gel was found to be an effective topical agent that considerably improves patient comfort postoperatively and can be considered a substitute of postoperative systemic antibiotics. Copyright © 2016 American Association of Oral and Maxillofacial Surgeons. Published by Elsevier Inc. All rights reserved.

  7. Topical liposomal Rose Bengal for photodynamic white hair removal: randomized, controlled, double-blind study.

    PubMed

    Samy, Nevien; Fadel, Maha

    2014-04-01

    Blond and white hair removal by laser is a complicated task with weak satisfactory results due to the deficiency in laser-absorbing chromophore. To investigate if repetitive sessions of photodynamic therapy (PDT) using external application of liposomal Rose bengal (RB) photosensitizer followed by intense pulsed light (IPL) exposure enables removal of gray and white hair. Rose bengal loaded in liposomes (LRB) was constructed, prepared in hydrogel, and was studied for some pharmaceutical properties. Penetration and selective hair follicle damage in mice skin were studied. Topical gel containing LRB was used for treating fifteen adult females who were complaining of facial white terminal hair. Unwanted facial hair was treated for three sessions at intervals of 4-6 weeks using intense pulsed light (IPL). At each session, the treatment area was pre-treated with topical LRB gel, while a control group of another 15 patients applied placebo gel before IPL treatment. Evaluations included hair regrowth, which was measured 4 weeks after each treatment session and at 6 months follow-up by counting the number of terminal hair compared with baseline pretreatment values. Treatment outcomes and complications if any were also reported. Average hair regrowth in the LRB group was 56% after 3 treatment cycles. After six-months follow up, average terminal hair count compared with baseline pretreatment showed 40% reduction and no recorded side effects. A significant difference (P<0.05) was seen compared with the control group; the clinical results were promising. Photodynamic hair removal using rose bengal-encapsulated liposomal gel in combination with IPL treatment showed significant efficacy in the treatment of white hair compared with a control group.

  8. Pirfenidone gel in patients with localized scleroderma: a phase II study.

    PubMed

    Rodríguez-Castellanos, Marco; Tlacuilo-Parra, Alberto; Sánchez-Enríquez, Sergio; Vélez-Gómez, Ezequiel; Guevara-Gutiérrez, Elizabeth

    2015-01-28

    Localized scleroderma is an inflammatory disease in its first stages and a fibrotic process in later stages, principally mediated by the transforming growth factor β. To date, there is no standard treatment. The objective of this study was to determine the effectiveness and safety of 8% pirfenidone gel in patients with localized scleroderma. This was an open phase II clinical trial that included 12 patients. Treatment with pirfenidone was indicated, three times daily for 6 months. Patients were evaluated clinically with the modified Localized Scleroderma Skin Severity Index (mLoSSI), as well with a durometer and histologically using hematoxylin and eosin stain and Masson's trichrome stain. The baseline mLoSSI average scores were 5.83 ± 4.80 vs. 0.83 ± 1.75 (P = 0.002) at 6 months. The initial durometer induration of the scleroderma plaques was 35.79 ± 9.10 vs. 32.47 ± 8.97 at 6 months (P = 0.05). We observed histopathological improvement with respect to epidermal atrophy, inflammation, dermal or adipose tissue fibrosis and annex atrophy from 12.25 ± 3.25 to 9.75 ± 4.35 (P = 0.032). The 8% pirfenidone gel application was well tolerated, and no side effects were detected. This is the first study on the therapeutic use of pirfenidone gel in localized scleroderma. It acts on both the inflammatory and the fibrotic phases. Considering its effectiveness, good safety profile and the advantage of topical application, pirfenidone is a treatment option in this condition.

  9. Biofilm community diversity after exposure to 0·4% stannous fluoride gels.

    PubMed

    Reilly, C; Rasmussen, K; Selberg, T; Stevens, J; Jones, R S

    2014-12-01

    To test the effect of 0·4% stannous fluoride (SnF2 ) glycerine-based gels on specific portions of the bacterial community in both a clinical observational study and in vitro multispecies plaque-derived (MSPD) biofilm model. Potential changes to specific portions of the bacterial community were determined through the Human Oral Microbial Identification Microarray (HOMIM). Both the observational clinical study and the biofilm model showed that short-term use of 0·4% SnF2 gel has little effect on the bacterial community depicted by hierarchical cluster analysis. The amount of plaque accumulation on a subject's teeth, which was measured by plaque index scores, failed to show statistical significant changes over the two baselines or after treatment (P = 0·9928). The in vitro results were similar when examining the effect of 0·4% SnF2 gels on biofilm adherence through a crystal violet assay (P = 0·1157). The bacteria within the dental biofilms showed resilience in maintaining the overall community diversity after exposure to 0·4% SnF2 topical gels. The study supports that the immediate benefits of using 0·4% SnF2 gels in children may be strictly from fluoride ions inhibiting tooth demineralization rather than delivering substantial antimicrobial effects. © 2014 The Society for Applied Microbiology.

  10. Active, motor-driven mechanics in a DNA gel.

    PubMed

    Bertrand, Olivier J N; Fygenson, Deborah Kuchnir; Saleh, Omar A

    2012-10-23

    Cells are capable of a variety of dramatic stimuli-responsive mechanical behaviors. These capabilities are enabled by the pervading cytoskeletal network, an active gel composed of structural filaments (e.g., actin) that are acted upon by motor proteins (e.g., myosin). Here, we describe the synthesis and characterization of an active gel using noncytoskeletal components. We use methods of base-pair-templated DNA self assembly to create a hybrid DNA gel containing stiff tubes and flexible linkers. We then activate the gel by adding the motor FtsK50C, a construct derived from the bacterial protein FtsK that, in vitro, has a strong and processive DNA contraction activity. The motors stiffen the gel and create stochastic contractile events that affect the positions of attached beads. We quantify the fluctuations of the beads and show that they are comparable both to measurements of cytoskeletal systems and to theoretical predictions for active gels. Thus, we present a DNA-based active gel whose behavior highlights the universal aspects of nonequilibrium, motor-driven networks.

  11. Dapsone gel 5% in combination with adapalene gel 0.1%, benzoyl peroxide gel 4% or moisturizer for the treatment of acne vulgaris: a 12-week, randomized, double-blind study.

    PubMed

    Fleischer, Alan B; Shalita, Alan; Eichenfield, Lawrence F; Abramovits, William; Lucky, Anne; Garrett, Steven

    2010-01-01

    To evaluate the safety and efficacy of dapsone gel 5% in the treatment of acne when used in combination with adapalene gel 0.1%, benzoyl peroxide gel 4% or moisturizer. This was a twelve-week, randomized, double-blind study. Patients aged 12 years and older (n=301) applied dapsone gel twice daily and were randomly assigned (1:1:1) to one of three additional treatments, applied once daily. By week 12, dapsone gel combined with any of the three additional treatments reduced the mean number of inflammatory lesions. However, the authors did not detect a significant difference in the reduction of inflammatory lesions when dapsone was used in combination with adapalene gel or with benzoyl peroxide gel compared to the dapsone plus moisturizer combination group (P=0.052 for both versus moisturizer combination). Patients treated with dapsone gel combined with adapalene showed a significantly better response in reduction in non-inflammatory and total acne lesion count than those who received the moisturizer combination. Local adverse reactions in all three treatment groups were minimal and generally mild in severity. Dapsone gel in combination with adapalene gel or benzoyl peroxide gel is safe and well tolerated for the treatment of acne vulgaris.

  12. A theory for fracture of polymeric gels

    NASA Astrophysics Data System (ADS)

    Mao, Yunwei; Anand, Lallit

    2018-06-01

    A polymeric gel is a cross-linked polymer network swollen with a solvent. If the concentration of the solvent or the deformation is increased to substantial levels, especially in the presence of flaws, then the gel may rupture. Although various theoretical aspects of coupling of fluid permeation with large deformation of polymeric gels are reasonably well-understood and modeled in the literature, the understanding and modeling of the effects of fluid diffusion on the damage and fracture of polymeric gels is still in its infancy. In this paper we formulate a thermodynamically-consistent theory for fracture of polymeric gels - a theory which accounts for the coupled effects of fluid diffusion, large deformations, damage, and also the gradient effects of damage. The particular constitutive equations for fracture of a gel proposed in our paper, contain two essential new ingredients: (i) Our constitutive equation for the change in free energy of a polymer network accounts for not only changes in the entropy, but also changes in the internal energy due the stretching of the Kuhn segments of the polymer chains in the network. (ii) The damage and failure of the polymer network is taken to occur by chain-scission, a process which is driven by the changes in the internal energy of the stretched polymer chains in the network, and not directly by changes in the configurational entropy of the polymer chains. The theory developed in this paper is numerically implemented in an open-source finite element code MOOSE, by writing our own application. Using this simulation capability we report on our study of the fracture of a polymeric gel, and some interesting phenomena which show the importance of the diffusion of the fluid on fracture response of the gel are highlighted.

  13. Postexposure protection of macaques from vaginal SHIV infection by topical integrase inhibitors.

    PubMed

    Dobard, Charles; Sharma, Sunita; Parikh, Urvi M; West, Rolieria; Taylor, Andrew; Martin, Amy; Pau, Chou-Pong; Hanson, Debra L; Lipscomb, Jonathan; Smith, James; Novembre, Francis; Hazuda, Daria; Garcia-Lerma, J Gerardo; Heneine, Walid

    2014-03-12

    Coitally delivered microbicide gels containing antiretroviral drugs are important for HIV prevention. However, to date, microbicides have contained entry or reverse transcriptase inhibitors that block early steps in virus infection and thus need to be given as a preexposure dose that interferes with sexual practices and may limit compliance. Integrase inhibitors block late steps after virus infection and therefore are more suitable for post-coital dosing. We first determined the kinetics of strand transfer in vitro and confirmed that integration begins about 6 hours after infection. We then used a repeat-challenge macaque model to assess efficacy of vaginal gels containing integrase strand transfer inhibitors when applied before or after simian/human immunodeficiency virus (SHIV) challenge. We showed that gel containing the strand transfer inhibitor L-870812 protected two of three macaques when applied 30 min before SHIV challenge. We next evaluated the efficacy of 1% raltegravir gel and demonstrated its ability to protect macaques when applied 3 hours after SHIV exposure (five of six protected; P < 0.05, Fisher's exact test). Breakthrough infections showed no evidence of drug resistance in plasma or vaginal secretions despite continued gel dosing after infection. We documented rapid vaginal absorption reflecting a short pharmacological lag time and noted that vaginal, but not plasma, virus load was substantially reduced in the breakthrough infection after raltegravir gel treatment. We provide a proof of concept that topically applied integrase inhibitors protect against vaginal SHIV infection when administered shortly before or 3 hours after virus exposure.

  14. Comparative Effects of Retinoic Acid or Glycolic Acid Vehiculated in Different Topical Formulations

    PubMed Central

    Maia Campos, Patrícia Maria Berardo Gonçalves; Gaspar, Lorena Rigo; Gonçalves, Gisele Mara Silva; Pereira, Lúcia Helena Terenciane Rodrigues; Semprini, Marisa; Lopes, Ruberval Armando

    2015-01-01

    Retinoids and hydroxy acids have been widely used due to their effects in the regulation of growth and in the differentiation of epithelial cells. However, besides their similar indication, they have different mechanisms of action and thus they may have different effects on the skin; in addition, since the topical formulation efficiency depends on vehicle characteristics, the ingredients of the formulation could alter their effects. Thus the objective of this study was to compare the effects of retinoic acid (RA) and glycolic acid (GA) treatment on the hairless mouse epidermis thickness and horny layer renewal when added in gel, gel cream, or cream formulations. For this, gel, gel cream, and cream formulations (with or without 6% GA or 0.05% RA) were applied in the dorsum of hairless mice, once a day for seven days. After that, the skin was analyzed by histopathologic, morphometric, and stereologic techniques. It was observed that the effects of RA occurred independently from the vehicle, while GA had better results when added in the gel cream and cream. Retinoic acid was more effective when compared to glycolic acid, mainly in the cell renewal and the exfoliation process because it decreased the horny layer thickness. PMID:25632398

  15. Viscoplastic fracture transition of a biopolymer gel.

    PubMed

    Frieberg, Bradley R; Garatsa, Ray-Shimry; Jones, Ronald L; Bachert, John O; Crawshaw, Benjamin; Liu, X Michael; Chan, Edwin P

    2018-06-13

    Physical gels are swollen polymer networks consisting of transient crosslink junctions associated with hydrogen or ionic bonds. Unlike covalently crosslinked gels, these physical crosslinks are reversible thus enabling these materials to display highly tunable and dynamic mechanical properties. In this work, we study the polymer composition effects on the fracture behavior of a gelatin gel, which is a thermoreversible biopolymer gel consisting of denatured collagen chains bridging physical network junctions formed from triple helices. Below the critical volume fraction for chain entanglement, which we confirm via neutron scattering measurements, we find that the fracture behavior is consistent with a viscoplastic type process characterized by hydrodynamic friction of individual polymer chains through the polymer mesh to show that the enhancement in fracture scales inversely with the squared of the mesh size of the gelatin gel network. Above this critical volume fraction, the fracture process can be described by the Lake-Thomas theory that considers fracture as a chain scission process due to chain entanglements.

  16. 46 CFR 173.007 - Location of the hook load.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... PERTAINING TO VESSEL USE Lifting § 173.007 Location of the hook load. When doing the calculations required in this subpart, the hook load must be considered to be located at the head of the crane. ...

  17. Reduced degree of irritation during a second cycle of ingenol mebutate gel 0.015% for the treatment of actinic keratosis.

    PubMed

    Jim On, Shelbi C; Haddican, Madelaine; Yaroshinsky, Alex; Singer, Giselle; Lebwohl, Mark

    2015-01-01

    Ingenol mebutate gel is a topical field treatment of actinic keratosis (AK). One of several proposed mechanisms of action for ingenol mebutate is induction of cell death in proliferating keratinocytes, suggesting a preferential action on AKs rather than healthy skin. Local skin reactions (LSRs) during 2 sequential 4-week cycles of AK treatment with ingenol mebutate gel 0.015% on the face or scalp were evaluated to test the hypothesis that reapplication of the study product would produce lower LSR scores than during the first treatment cycle. In this unblinded study, 20 participants with AKs on the face or scalp were treated with ingenol mebutate gel 0.015% once daily for 3 days in 2 sequential 4-week cycles. Composite LSR scores were evaluated during both cycles. The composite LSR score during the second cycle was found to be significantly lower than the first cycle (P=.0002). The proportion of participants who experienced LSRs in the second treatment cycle was less than the first cycle. Ingenol mebutate gel 0.015% may cumulatively reduce the burden of sun-damaged skin over 2 treatment cycles by targeting and removing transformed keratinocytes.

  18. Effects of Minoxidil Gel on Burn Wound Healing in Rats

    PubMed Central

    Khazaeli, Payam; Karamouzian, Mohammad; Rohani, Shohreh; Sadeghirad, Behnam; Ghalekhani, Nima

    2014-01-01

    Minoxidil has been reported to inhibit in-vitro fibroblast proliferation and lysyl hydroxylase activity, a key enzyme in collagen biosynthesis. These in-vitro effects proposed minoxidil to be a potential antifibrotic agent. The present study aimed to investigate the effects of minoxidil gel on wound healing procedure in a second-degree burn model in rats. Wistar rats were anesthetized and a second-degree burn was induced on the back of Wistar rats using a heated 2 cm diameter metal plate. Experimental groups received 2% or 5% topical minoxidil gel, dexpanthenol or sliver sulfadiazine. Histological parameters including collagen content, angiogenesis, number of preserved follicles and necrosis along with tensile strength of burn wound area were assessed on days 3, 7, 14 and 21 post-injury.Microscopic evaluation of specimens collected from sample animals were consistent and showed a second-degree burn. Main histological findings regarding minoxidil topical usage showed that collagen content and tensile strength of burned area did not differ between groups. However, minoxidil increased the number and diameter of blood vessels significantly compared with other groups.Although minoxidil improved the process of wound-healing, our results did not support the proposed idea of its usage as an antifibrotic agent. However, to reject its possible effects as an antifibrotic agent, more objective animal models should be developed and studied. PMID:24734077

  19. The Gel Electrophoresis Markup Language (GelML) from the Proteomics Standards Initiative

    PubMed Central

    Gibson, Frank; Hoogland, Christine; Martinez-Bartolomé, Salvador; Medina-Aunon, J. Alberto; Albar, Juan Pablo; Babnigg, Gyorgy; Wipat, Anil; Hermjakob, Henning; Almeida, Jonas S; Stanislaus, Romesh; Paton, Norman W; Jones, Andrew R

    2011-01-01

    The Human Proteome Organisation’s Proteomics Standards Initiative (HUPO-PSI) has developed the GelML data exchange format for representing gel electrophoresis experiments performed in proteomics investigations. The format closely follows the reporting guidelines for gel electrophoresis, which are part of the Minimum Information About a Proteomics Experiment (MIAPE) set of modules. GelML supports the capture of metadata (such as experimental protocols) and data (such as gel images) resulting from gel electrophoresis so that laboratories can be compliant with the MIAPE Gel Electrophoresis guidelines, while allowing such data sets to be exchanged or downloaded from public repositories. The format is sufficiently flexible to capture data from a broad range of experimental processes, and complements other PSI formats for mass spectrometry data and the results of protein and peptide identifications to capture entire gel-based proteome workflows. GelML has resulted from the open standardisation process of PSI consisting of both public consultation and anonymous review of the specifications. PMID:20677327

  20. The X-ray Absorber in the X-ray Transient NLS1 WPVS 007

    NASA Astrophysics Data System (ADS)

    Grupe, Dirk

    This proposal is for a funding request for an approved XMM-Newton observations of the X-ray transient Narrow-Line Seyfert 1 galaxy WPVS 007. The request is for 4 month of salary for the PI for one year in order to do the data analysis, publish the results, and attend an international AGN meeting. XMM will observe WPVS 007 in June 2010 simultaneously with HST, Chandra, and Swift. The goal is to establish a tight connection between the UV broad absorption line troughs found in FUSE observations and the strong partial covering absorber feature found by Swift. WPVS 007 showed a dramatic transformation into a Broad Absorption line QSO like AGN between a 1996 HST observation and a 2003 FUSE observation. Several Swift monitoring observations have suggested that the absorber may have started to disappear. Therefore it is crucial for our HST COS UV spectroscopy to know what the status of the X-ray absorber is. The XMM observation will provide a well-exposed X-ray spectrum even if WPVS 007 will be in a low flux state. This spectrum will enable us to put constraints on the absorption column density and covering fraction of the partial covering absorber.

  1. A novel smart supramolecular organic gelator exhibiting dual-channel responsive sensing behaviours towards fluoride ion via gel-gel states.

    PubMed

    Mehdi, Hassan; Pang, Hongchang; Gong, Weitao; Dhinakaran, Manivannan Kalavathi; Wajahat, Ali; Kuang, Xiaojun; Ning, Guiling

    2016-07-07

    A novel smart supramolecular organic gelator G-16 containing anion and metal-coordination ability has been designed and synthesized. It shows excellent and robust gelation capability as a strong blue fluorescent supramolecular organic gel OG in DMF. Addition of Zn(2+) produced Zn(2+)-coordinated supramolecular metallogel OG-Zn. Organic gel OG and organometallic gel OG-Zn exhibited efficient and different sensing behaviors towards fluoride ion due to the variation in self-assembling nature. Supramolecular metallogel OG-Zn displayed specific selectivity for fluoride ion and formed OG-Zn-F with dramatic color change from blue to blue green in solution and gel to gel states. Furthermore after directly addition of fluoride into OG produced fluoride containing organic gel OG-F with drastically modulation in color from blue to greenish yellow fluorescence via strong aggregation-induced emission (AIE) property. A number of experiments were conducted such as FTIR, (1)H NMR, and UV/Vis spectroscopies, XRD, SEM and rheology. These results revealed that the driving forces involved in self-assembly of OG, OG-Zn, OG-Zn-F and OG-F were hydrogen bonding, metal coordination, π-π interactions, and van der Waal forces. In contrast to the most anion responsive gels, particularly fluoride ion responsive gels showed gel-sol state transition on stimulation by anions, the gel state of OG and OG-Zn did not show any gel-to-sol transition during the whole F(-) response process.

  2. Advances in development, scale-up and manufacturing of microbicide gels, films, and tablets.

    PubMed

    Garg, Sanjay; Goldman, David; Krumme, Markus; Rohan, Lisa C; Smoot, Stuart; Friend, David R

    2010-12-01

    Vaginal HIV microbicides are topical, self administered products designed to prevent or significantly reduce transmission of HIV infection in women. The earliest microbicide candidates developed have been formulated as coitally dependent (used around the time of sex) gels and creams. All microbicide candidates tested in Phase III clinical trials, so far, have been gel products with non-specific mechanisms of action. However, recently, research is focusing on compounds containing highly potent and specific anti-retrovirals. These specific anti-retrovirals are being formulated as primary dosage forms such as vaginal gels or in alternative dosage forms such as fast dissolve films and tablets. Recent innovations also include development of combination products of highly active antiviral drugs such as reverse transcriptase inhibitors and entry inhibitors, which would theoretically be more effective and would reduce the possibility of drug resistance. In this article, an overview of recent advances in the microbicide gel, film, and tablet formulations and issues pertaining to scale-up, formulation, and evaluation challenges and regulatory guidelines have been presented. This article forms part of a special supplement covering presentations on gels, tablets, and films from the symposium on "Recent Trends in Microbicide Formulations" held on 25 and 26 January 2010, Arlington, VA. Copyright © 2010 Elsevier B.V. All rights reserved.

  3. Efficacy and safety of diclofenac diethylamine 1.16% gel in acute neck pain: a randomized, double-blind, placebo-controlled study.

    PubMed

    Predel, Hans-Georg; Giannetti, Bruno; Pabst, Helmut; Schaefer, Axel; Hug, Agnes M; Burnett, Ian

    2013-08-21

    Neck pain (NP) is a common musculoskeletal disorder in primary care that frequently causes discomfort. Non-steroidal anti-inflammatory drugs (NSAIDs) may be used to reduce neck pain and associated inflammation and facilitate earlier recovery. Topical diclofenac diethylamine (DDEA) 1.16% gel is clinically proven to be effective and well tolerated in acute and chronic musculoskeletal conditions, but until now no clinical data existed for its use in acute NP. The aim of this study was to assess the efficacy and safety of DDEA 1.16% gel compared with placebo gel in acute NP. In a randomized, double-blind, placebo-controlled study, patients with acute NP (n = 72) were treated with DDEA 1.16% gel (2 g, 4x/day, for 5 days) or placebo. Efficacy assessments included pain-on-movement (POM), pain-at-rest (PAR), functional neck disability index (NDI) and response to treatment (decrease in POM by 50% after 48 h). Adverse events (AEs) were recorded throughout the study. The primary outcome, POM at 48 h, was statistically significantly lower with DDEA gel (19.5 mm) vs. placebo (56.9 mm) (p < 0.0001), representing a clinically relevant decrease from baseline (75% vs. 23%, respectively). All POM scores were significantly lower with DDEA gel vs. placebo from 1 h, as were PAR and NDI scores from first assessment (24 h) onwards (all p < 0.0001). Response to treatment was significantly higher with DDEA gel (94.4%) vs. placebo (8.3%) (p < 0.0001). There were no AEs with DDEA gel. DDEA 1.16% gel, which is available over-the-counter, was effective and well tolerated in the treatment of acute neck pain. The tools used to assess efficacy suggest that it quickly reduced neck pain and improved neck function. However, questions remain regarding the comparability and validity of such tools. Further studies will help ascertain whether DDEA 1.16% gel offers an alternative treatment option in this common, often debilitating condition. ClinicalTrials.gov identifier: NCT

  4. Osmolarity as a contributing factor in topical drug delivery

    NASA Astrophysics Data System (ADS)

    Funke, Claire; Szeri, Andrew J.

    2017-11-01

    Gels and dissolvable solids are drug delivery platforms being evaluated for application of active pharmaceutical ingredients, termed microbicides, which act topically against infection by sexually transmitted HIV. In previous work, we have investigated how dilution by naturally produced fluid from the vaginal mucosa affects drug transport into the vaginal wall. We expand on this work by no longer assuming a constant flux and instead developing a relation for fluid transport based on osmolarity - thus allowing fluid to pass both into and out of epithelial cells. This relation shows that varying the osmolarity of the applied solution can have a significant effect on the amount of drug delivered to its target while holding the applied amount constant. This effect is modulated by a dimensionless group that relates the rates of solute and solvent transport. Ultimately, our goal is to develop a tool to understand better how to manipulate solution osmolarity in order to improve drug delivery within safety parameters for mucosal tissue.

  5. Topical photosan-mediated photodynamic therapy for DMBA-induced hamster buccal pouch premaligant lesions: an in vivo study

    NASA Astrophysics Data System (ADS)

    Hsu, Yih-Chih; Chiang, Chun-Pin; Chen, Jian Wen; Chen, Ying-Ru; Lee, Jeng-Woei

    2010-02-01

    One of the best strategies to prevent the occurrence of oral cancer is to eliminate oral precancers and block their further malignant transformation. Previous studies showed that photosan-mediated photodynamic therapy (photosan-PDT) is very effective for human head and neck cancers. To avoid the systemic photodynamic toxicity of photosan, this study was designed to use a topical photosan-PDT for treatment of DMBA-induced hamster buccal pouch precancerous lesions. Twelve 10-week-old male Syrian golden hamsters were used in this study. DMBA was applied to the left buccal pouches thrice a week for 8 to 10 weeks and mineral oil was painted on the right buccal pouches thrice a week for 8 to 10 weeks as the normal controls. Six hamsters were euthanized for tissue harvest. Precancerous lesions of moderate to severe dysplasia were consistently induced and proven by histological examination. These induced precancerous lesions in the remaining 6 hamsters were used for testing the efficacy of topical photosan-PDT. Before PDT, fluorescence spectroscopy was used to determine when protoporphyrine IX (PpIX) reached its peak level in the lesional epithelial cells after topical application of photosan-gel. We found that PpIX reached its peak level in precancerous lesions about 13.5 min after topical application of photosan-gel. The precancerous lesions in 4 hamsters were treated with topical photosan-PDT using the 635-nm LED light once or twice a week. Complete regression of the precancerous lesions was found after 2-4 PDT treatments by visual and histological examination. Our findings indicate that topical photosan-PDT is a very effective treatment modality for DMBA-induced hamster buccal pouch precancerous lesions.

  6. Clindamycin Topical

    MedlinePlus

    ... gel, a solution (liquid), a lotion, and a pledget (swab) to apply to the skin. The foam ... usually applied once a day. The solution, lotion, pledgets, and most brands of gel are applied twice ...

  7. The anti-inflammatory effect of topical tofacitinib on immediate and late-phase cutaneous allergic reactions in dogs: a placebo-controlled pilot study.

    PubMed

    Blubaugh, Amanda; Rissi, Daniel; Elder, Deborah; Denley, Tara; Eguiluz-Hernandez, Sitka; Banovic, Frane

    2018-03-06

    Topical Janus kinase (JAK) inhibition is a promising therapeutic target for several inflammatory skin diseases of humans. To evaluate the anti-inflammatory effect of tofacitinib, a JAK 1/3 inhibitor, on immediate and late-phase skin reactions in dogs. Five healthy laboratory beagle dogs. Topical tofacitinib (total daily dosage: 0.5 mg/cm 2 ) or its gel vehicle were applied on either the left or right lateral thorax of each dog for eight days. Three days before application and after eight days of topical treatment, intradermal injections of histamine and anticanine-IgE antibodies were performed on both sides; they were evaluated by an investigator blinded to the interventions. The tofacitinib gel was well-tolerated; one dog developed mild erythema at Day 5 that resolved by the next application. Treatment with tofacitinib reduced histamine and anticanine-IgE global wheal scores (one-way ANOVA, P ≤ 0.005 for both) compared to baseline; there was no significant difference for the vehicle placebo (histamine; P = 0.163; IgE, P = 0.223). Late-phase reactions (LPRs) were markedly, but not significantly reduced after tofacitinib treatment (P = 0.071). A blinded histological evaluation of 6 h-anti-IgE-associated LPRs revealed a significant reduction in the total leucocyte superficial dermal cellularity (P = 0.022), as well as eosinophil (P = 0.022) and mast cell (P = 0.022) counts at tofacitinib-treated sides compared with pretreatment values. Post-treatment complete blood counts and serum chemistry profiles did not show relevant tofacitinib-induced changes. Our observations suggest that topical tofacitinib exerts an inhibitory effect on activated canine skin-emigrating immune cells; this drug should be investigated further as a topical immunosuppressive drug in dogs. © 2018 ESVD and ACVD.

  8. sts132-s-007

    NASA Image and Video Library

    2010-05-14

    STS132-S-007 (14 May 2010) --- Space shuttle Atlantis and its six-member STS-132 crew head toward Earth orbit and rendezvous with the International Space Station. Liftoff was at 2:20 p.m. (EDT) on May 14, 2010, from launch pad 39A at NASA's Kennedy Space Center. Onboard are NASA astronauts Ken Ham, commander; Tony Antonelli, pilot; Garrett Reisman, Michael Good, Steve Bowen and Piers Sellers, all mission specialists. The crew will deliver the Russian-built Mini-Research Module 1 (MRM-1) to the International Space Station. Named Rassvet, Russian for "dawn," the module is the second in a series of new pressurized components for Russia and will be permanently attached to the Earth-facing port of the Zarya Functional Cargo Block (FGB). Rassvet will be used for cargo storage and will provide an additional docking port to the station. Also aboard Atlantis is an Integrated Cargo Carrier, or ICC, an unpressurized flat bed pallet and keel yoke assembly used to support the transfer of exterior cargo from the shuttle to the station. STS-132 is the 34th mission to the station and the last scheduled flight for Atlantis.

  9. Topical medication instillation techniques for glaucoma

    PubMed Central

    Xu, Li; Wang, Xuemei; Wu, Meijing

    2017-01-01

    (122 eyes of 61 participants) that had evaluated a topical medication instillation technique. We also identified two ongoing trials. Both included trials used a within-person design and administered prostaglandin monotherapy for glaucoma or ocular hypertension. Because the trials evaluated different instillation techniques and assessed different outcomes, we performed no meta-analysis. One trial, conducted in the US, evaluated the effect of eyelid closure (one and three minutes) versus no eyelid closure on lowering IOP. At one to two weeks' follow-up, reduction in IOP was similar in the eyelid closure group and the no eyelid closure group (mean difference (MD) -0.33 mmHg, 95% confidence interval (CI) -0.8 to 1.5; 51 participants; moderate-certainty evidence). The second trial, conducted in Italy, evaluated the effect of using an absorbent cloth to wipe excess fluid after instillation (fluid removal) versus not using an absorbent cloth (no removal) on reducing dermatologic adverse events. At four months' follow-up, eyelashes were shorter among eyes in the fluid removal group compared with the no fluid removal group (MD -1.70 mm, 95% CI -3.46 to 0.06; 10 participants; low-certainty evidence). Fewer eyes showed skin hyperpigmentation in the eyelid region towards the nose in the fluid removal group compared with the no removal group (RR 0.07, 95% CI 0.01 to 0.84; 10 participants; low-certainty evidence); however, the difference was uncertain in the eyelid region towards the temples (RR 0.44, 95% CI 0.07 to 2.66; 10 participants; low-certainty evidence). The effect hypertrichosis (excessive hair growth) was uncertain between groups (RR 1.00, 95% CI 0.17 to 5.98; 10 participants; low-certainty evidence). Neither trial reported other outcomes specified for this review, including the proportion of participants with IOP less than 21 mmHg; participant-reported outcomes related to the ease, convenience, and comfort of instillation techniques; physiologic measurements of systemic

  10. MIGS: therapeutic success of combined Xen Gel Stent implantation with cataract surgery.

    PubMed

    Hohberger, Bettina; Welge-Lüßen, Ulrich-Christoph; Lämmer, Robert

    2018-03-01

    Glaucoma, a common disease in the elderly population, is frequently coexistent with cataract. While the combination of filtration surgery and cataract surgery is a challenging topic with limited success, minimal invasive glaucoma surgery (MIGS), such as Xen Gel Stents, seems to provide promising results. The aim of this study was to investigate the complete and qualified therapeutic success of Xen Gel Stent implantation with (XenPhaco) and without cataract surgery. One hundred and eleven open-angle glaucoma eyes underwent implantation of Xen45 Gel Stent (AqueSys, Inc.) with or without cataract operation. Complete therapeutic success was defined as target intraocular pressure (IOP) < 18 mmHg at any time point within 6 months of follow-up without local antiglaucomatous therapy or further surgical interventions. Qualified success was defined as target IOP <18 mmHg with additional 1-2 local antiglaucomatous eye drops. Failure included all cases with the necessity of at least three local antiglaucomatous eye drops or additional glaucoma surgery. Combined implantation of Xen Gel Stent with cataract surgery was performed in 30 eyes and stand-alone Xen Gel Stent implantation was performed in 81 eyes. A complete therapeutic success was achieved in 46.9% of single Xen Gel Stent implantation, whereas 53.3% was reached with combined XenPhaco. Qualified success was seen in 2.5% in the eyes of the single Xen Gel Stent implantation group and in 3.3% of the combined surgery group. Therapeutic failure rate was 49.4% in the stand-alone group vs 46.7% in the combined group. Data were not significantly different for group and subgroup analyses. Complete and qualified therapeutic success is similar for the combination of Xen Gel Stent implantation with and without cataract surgery in open-angle glaucoma patients. MIGS using Xen Gel Stent can be recommended in situations if glaucoma surgery is indicated besides coexisting cataract.

  11. [Effect of M007 mediated photodynamic therapy on proliferation of human osteosarcoma MG63 cells in vitro].

    PubMed

    Zhou, Yu-Kai; Wu, Wen-Zhi; Zhang, Lan; Yang, Chun-Hui; Wang, Yan-Ping

    2012-01-01

    To investigate the effect of a new photosensitizer, M007 mediated photodynamic therapy on proliferation of human osteosarcoma MG63 cells in vitro. Human osteosarcoma MG63 cells were prepared as 1 x 10(6) /mL single-cell suspension, and 1 mL cells were transferred into 60 mL culture dish, then treated with 5 different gradient dosages (0, 2, 4, 8, 16 micromol/L) of M007 followed by photodynamic therapy or dark reaction for 10 min. The survival rate of the cells and the mode of cell death were detected by flow cytometry with the stain of Annexin V-FITC/PI. The effect on proliferation of survival cells was observed by MTT assay and colony-forming assay. M007 mediated photodynamic therapy induced the inactivation of MG63 human osteosarcoma cells in the way of late apoptosis/necrosis or becoming naked nucleus predominately. More than 90% MG63 cells in M007-PDT group were dead under the treatment of 2-16 micromol/L M007. The survival rates of 4-16 micromol/L M007-PDT group were steadily less than 1%. The optical densities did not increase with extension of culture time in 2-8 micromol/L M007-PDT group (P > 0.05). There were 16 survival alive cells found occasionally in 2 micromol/L M007-PDT group, but no colonies found in other groups. M007 mediated photodynamic therapy totally inactivated human osteosarcoma MG63 cells in vitro with the dosage more than 4 micromol/L.

  12. Skin hydration and cooling effect produced by the Voltaren® vehicle gel.

    PubMed

    Hug, Agnes M; Schmidts, Thomas; Kuhlmann, Jens; Segger, Dörte; Fotopoulos, Grigorios; Heinzerling, Johanna

    2012-05-01

    Voltaren vehicle gel is the carrier substance of the topical Voltaren products. This vehicle gel is especially formulated to be easily applied on the skin, while providing some sensory benefits. The present study aims to substantiate the widely perceived hydrating and cooling effect of Voltaren vehicle gel. Volar forearm skin hydration and transepidermal water loss (TEWL) were measured and user satisfaction was evaluated by questionnaires, after application in 31 healthy, female volunteers. The cooling effect was investigated for 40 min with thermal imaging on 12 forearm sites of six healthy subjects. Voltaren vehicle gel application increased skin hydration by 13.1% (P = 0.0002) when compared with the untreated site, 8 h after the final treatment after 2 weeks. TEWL decreased on both treated (0.37 g/m(2) /h) and untreated (0.74 g/m(2) /h) forearm sites after 2 weeks (8 h after last treatment), demonstrating a relative increase of 6.5% in water loss. Voltaren vehicle gel application resulted in a rapid reduction of skin surface temperature by 5.1°C after only 3 min with an average maximum reduction of 5.8°C after 10 min. The cooling effect was experienced by 94% subjects, while 74% felt that their skin became softer. No adverse events, including skin irritation, were reported during the study and by the 37 participants. This study showed a statistically significant increase in skin hydration as well as a rapid cooling effect lasting approximately 30 min, after application of Voltaren vehicle gel. The small relative increase in water loss may be attributed to an additional skin surface water loss secondary to the increased water content brought into the skin by the Voltaren vehicle gel. The use did not induce any skin irritation and was found acceptable to use by the majority of participants. © 2011 John Wiley & Sons A/S.

  13. Effect of transdermal glyceryl trinitrate and anti-inflammatory gel in infusion phlebitis.

    PubMed

    Cökmez, Atilla; Gür, Serhat; Genç, Hüdai; Deniz, Sümer; Tarcan, Ercüment

    2003-10-01

    Phlebitis is the commonest complication of intravenous infusion. It has been suggested that it is initiated by venoconstriction at the infusion site, hence treatment with a vasodilator may reduce its incidence. A prospective controlled study was carried out on the effect of transdermal glyceryl trinitrate (GTN) and topical anti-inflammatory gel (non-steroidal anti-inflammatory drug; NSAID) on the survival of peripheral intravenous infusion in 386 patients. A total of 34.9% (43 out of 123) of the infusions failed in the control group compared with 14.1% (18 out of 127) in the NSAID group (P < 0.05) and 30.8% (43 out of 136) in the GTN group (P < 0.05). In the control group 31 positive cultures were obtained. Twenty-one positive cultures were obtained in the GTN group and four cases of bacterial proliferation were observed in the NSAID group. Infusion phlebitis is a common problem in hospitalized patients and its incidence can be effectively reduced by NSAI gel and GTN but NSAI gel is more effective than GTN.

  14. Evaluation of the enzymatic activity and stability of commercial bromelain incorporated in topical formulations.

    PubMed

    Lourenço, C B; Ataide, J A; Cefali, L C; Novaes, L C D L; Moriel, P; Silveira, E; Tambourgi, E B; Mazzola, P G

    2016-10-01

    Bromelain is a mixture of proteolytic enzymes found in various tissues of the pineapple plant (Ananas comosus) and other species of Bromeliaceae. Owing to its proteolytic activity, bromelain has been used in the food, medical, pharmaceutical and cosmetic industries, for its cell renewal, anti-ageing, whitening and anti-cellulite properties. This study evaluated the stability of bromelain (commercial powder) incorporated in topical formulations. Bromelain was incorporated at three concentrations, 0.5%, 1.0% and 2.0%, in oil-in-water emulsion and gel, and stored for six months at varying stress conditions. Stability was accessed by measuring the changes in the protein content, enzymatic activity, viscosity, rheology, pH and colour of the selected formulations. The colour of all the samples changed after 180 days of incubation, indicating the concentration-dependence and temperature-sensitive nature of these formulations. No relationship was observed between the changes in the pH, temperature and luminosity exposure in all the samples. Gels proved to be the least preferred base for incorporation of bromelain for use as a topical formulation, owing to its inability to maintain the integrity of bromelain, thereby affecting the formulation characteristics. The emulsion-based formulations at all the concentrations of bromelain were more stable than the gel-based formulation over 180 days of evaluation, at a temperature of 5°C, protected from light. © 2016 Society of Cosmetic Scientists and the Société Française de Cosmétologie.

  15. CONFORMANCE IMPROVEMENT USING GELS

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Randall S. Seright

    2003-09-01

    This report describes work performed during the second year of the project, ''Conformance Improvement Using Gels.'' The project has two objectives. The first objective is to identify gel compositions and conditions that substantially reduce flow through fractures that allow direct channeling between wells, while leaving secondary fractures open so that high fluid injection and production rates can be maintained. The second objective is to optimize treatments in fractured production wells, where the gel must reduce permeability to water much more than that to oil. Pore-level images from X-ray computed microtomography were re-examined for Berea sandstone and porous polyethylene. This analysismore » suggests that oil penetration through gel-filled pores occurs by a gel-dehydration mechanism, rather than a gel-ripping mechanism. This finding helps to explain why aqueous gels can reduce permeability to water more than to oil. We analyzed a Cr(III)-acetate-HPAM gel treatment in a production well in the Arbuckle formation. The availability of accurate pressure data before, during, and after the treatment was critical for the analysis. After the gel treatment, water productivity was fairly constant at about 20% of the pre-treatment value. However, oil productivity was stimulated by a factor of 18 immediately after the treatment. During the six months after the treatment, oil productivity gradually decreased to approach the pre-treatment value. To explain this behavior, we proposed that the fracture area open to oil flow was increased substantially by the gel treatment, followed by a gradual closing of the fractures during subsequent production. For a conventional Cr(III)-acetate-HPAM gel, the delay between gelant preparation and injection into a fracture impacts the placement, leakoff, and permeability reduction behavior. Formulations placed as partially formed gels showed relatively low pressure gradients during placement, and yet substantially reduced the flow capacity

  16. Epidemic models for phase transitions: application to a physical gel

    NASA Astrophysics Data System (ADS)

    Bilge, A. H.; Pekcan, O.; Kara, S.; Ogrenci, A. S.

    2017-09-01

    Carrageenan gels are characterized by reversible sol-gel and gel-sol transitions under cooling and heating processes and these transitions are approximated by generalized logistic growth curves. We express the transitions of carrageenan-water system, as a representative of reversible physical gels, in terms of a modified Susceptible-Infected-Susceptible epidemic model, as opposed to the Susceptible-Infected-Removed model used to represent the (irreversible) chemical gel formation in the previous work. We locate the gel point Tc of sol-gel and gel-sol transitions and we find that, for the sol-gel transition (cooling), Tc > Tsg (transition temperature), i.e. Tc is earlier in time for all carrageenan contents and moves forward in time and gets closer to Tsg as the carrageenan content increases. For the gel-sol transition (heating), Tc is relatively closer to Tgs; it is greater than Tgs, i.e. later in time for low carrageenan contents and moves backward as carrageenan content increases.

  17. Electrophoresis of DNA in agarose gels, polyacrylamide gels and in free solution

    PubMed Central

    Stellwagen, Nancy C.

    2009-01-01

    This review describes the electrophoresis of curved and normal DNA molecules in agarose gels, polyacrylamide gels and in free solution. These studies were undertaken to clarify why curved DNA molecules migrate anomalously slowly in polyacrylamide gels but not in agarose gels. Two milestone papers are cited, in which Ferguson plots were used to estimate the effective pore size of agarose and polyacrylamide gels. Subsequent studies on the effect of the electric field on agarose and polyacrylamide gel matrices, DNA interactions with the two gel matrices, and the effect of curvature on the free solution mobility of DNA are also described. The combined results suggest that the anomalously slow mobilities observed for curved DNA molecules in polyacrylamide gels are due primarily to preferential interactions of curved DNAs with the polyacrylamide gel matrix; the restrictive pore size of the matrix is of lesser importance. In free solution, DNA mobilities increase with increasing molecular mass until leveling off at a plateau value of (3.17 ± 0.01) × 10-4 cm2/Vs in 40 mM Tris-acetate-EDTA buffer at 20°C. Curved DNA molecules migrate anomalously slowly in free solution as well as in polyacrylamide gels, explaining why the Ferguson plots of curved and normal DNAs containing the same number of base pairs extrapolate to different mobilities at zero gel concentration. PMID:19517510

  18. Simple Preparation of Timolol 0.5% Gel from Eye Drop Solution for Superficial Infantile Hemangiomas.

    PubMed

    Choo, Winnie

    2017-01-01

    The discovery of beta-adrenergic blocker effects on infantile hemangiomas has affected the choice of treatment in recent years. Oral propranolol is effective in treating infantile hemangiomas, but the risk of systemic side effects remains a concern. Data from literature review reported positive clinical outcomes with no major adverse effects observed in children using topical beta-blocker such as timolol maleate. Topical application of timolol eye drop has been mentioned in few studies, most of which reported that the solution cannot stay on the site of application due to its fluidity. Adding hydroxyethyl cellulose into a timolol solution increased its viscosity by forming a hydrogel and thus changed the rheology property. The compounded timolol gel exhibited thixotropy property allowing better and longer contact at sites of application. Experimental data from literature review showed desirable characteristics and measurable flux of timolol across human stratum corneum. Gel dosage form allows easy and precise application and maximizes timolol's therapeutic efficacy at the sites of application. Copyright© by International Journal of Pharmaceutical Compounding, Inc.

  19. Lippia sidoides and Myracrodruon urundeuva gel prevents alveolar bone resorption in experimental periodontitis in rats.

    PubMed

    Botelho, M A; Rao, V S; Carvalho, C B M; Bezerra-Filho, J G; Fonseca, S G C; Vale, M L; Montenegro, D; Cunha, F; Ribeiro, R A; Brito, G A

    2007-09-25

    In Brazilian folk medicine, Lippia sidoides (Ls) and Myracrodruon urundeuva (Mu) have gained popularity and reputation as effective antimicrobial and anti-inflammatory agents. This work aimed to evaluate the effect of topical herbal gel from Ls 0.5% (v/w) and Mu 5% (w/w) in experimental periodontal disease (EPD) in rats. Wistar rats were subjected to ligature placement around the second upper left molars. Animals were treated topically with Ls and/or Mu-based gel, immediately after EPD induction and three times/day for 11 days until the rats were sacrificed (11th day). Saline-based gel was utilized as control for all experiments and doxycycline based gel 10% (w/w) was utilized as reference substance. Animals were weighed daily. Alveolar bone loss was measured as the difference (in millimeters) between the cusp tip and the alveolar bone. The periodontum and the surrounding gingivae were examined at histopathology, as well as the neutrophil influx into the gingivae was assayed using myeloperoxidase activity and cytokine production mainly tumor necrosis factor-alpha (TNF-alpha) and interleukin-1beta (IL-1beta) levels by ELISA method. The local bacterial flora was assessed through culture of the gingival tissue in standard aerobic and anaerobic media. Alveolar bone loss was significantly inhibited by Ls and Mu combined treatment compared to the saline control group. Ls and Mu combined treatment reduced tissue lesion at histopathology, with partial preservation of the periodontum, coupled to decreased myeloperoxidase activity as well as significantly inhibited TNF-alpha and IL-1beta production in gingival tissue compared to the saline control group. Ls and Mu combined treatment also prevented the growth of oral microorganisms and the weight loss. Ls and Mu combined based gel treatment preserved alveolar bone resorption and demonstrated anti-inflammatory and antibacterial activities in experimental periodontitis.

  20. GAS-007: First step in a series of Explorer payloads

    NASA Technical Reports Server (NTRS)

    Kitchens, Philip H.

    1987-01-01

    As part of the NASA Get Away Special program for flying small, self-contained payloads onboard the Space Shuttle, the Alabama Space and Rocket Center (ASRC) in Huntsville has sponsored three such payloads for its Project Explorer. One of these is GAS-007, which was carried originally on STS mission 41-G in early October 1984. Due to an operational error it was not turned on and was, therefore, subsequently rescheduled and flown on mission 61-C. This paper will review Explorer's history, outline its experiments, present some preliminary experimental results, and describe future ASRC plans for Get Away Special activities, including follow-on Explorers GAS-105 and GAS-608.

  1. Preparation and evaluation of niosome gel containing acyclovir for enhanced dermal deposition.

    PubMed

    Jacob, Shery; Nair, Anroop B; Al-Dhubiab, Bandar E

    2017-12-01

    Niosomes suggest a versatile vesicle delivery system with possible transport of drugs via topical route for skin delivery. The aim of the present research was to optimize niosome gel formulation of acyclovir and to evaluate in both in vitro and in vivo rabbit model. Niosome formulations were formulated by coacervation phase separation technique with different ratios of nonionic surfactants, phospholipids and cholesterol using 3 2 factorial design. Altering the surfactant concentration has influenced the drug entrapment, but not vesicle size. At high surfactant combinations, the acyclovir release from niosomes was strongly influenced by cholesterol:lecithin ratio. Ex vivo drug permeation data indicate substantial difference in flux values and was influenced by the niosome composition. Ex vivo studies using formulation (B 8 ) for drug deposition indicate greater amount of niosome being diffused into the skin layers and formed a depot, compared to commercial acyclovir cream (control). Two distinct dermatopharmacokinetic profiles were observed, in vivo, for niosome gel formulation (B 8 ) and control, which were analog to the profiles observed with ex vivo deposition studies. In vivo plasma drug level suggests low systemic exposure of acyclovir (C max : 9.44 ± 2.27 ng/mL and 14.54 ± 3.11 ng/mL for niosome formulation and control, respectively). Comparison of kinetic data of acyclovir in the stratum corneum and plasma signifies that the niosome formulation forms a depot in the epidermis or dermis region. This study concludes that the niosome gel formulation (B 8 ) could be a viable vesicular system for an impressive transdermal delivery of acyclovir by topical application.

  2. Topical nonsteroidal anti-inflammatory drugs versus oil of evening primrose in the treatment of mastalgia.

    PubMed

    Qureshi, S; Sultan, N

    2005-02-01

    To compare oil of evening primrose (OEP) and topical nonsteroidal anti-inflammatory (NSAIDs) with respect to safety, effectiveness, rapidity of response, cost effectiveness and acceptability in the treatment of breast pain. An open, non-randomised, comparative study of topical (NSAI) gel versus OEP was carried out, over a period of one year. Fifty female patients attending the outpatient department with moderate to severe breast pain were given one of the two agents alternatively, after selection. Results showed that out of 25 patients treated with OEP, 64% had a clinically significant response after three months of treatment, compared with 92% with topical NSAIDs. Only one patient (4%) had side effects with OEP, while no patient had side effects with topical NSAIDs. Twenty per cent and seventy per cent showed acceptability as far as costs were concerned and mode of administration respectively, with OEP. The acceptability rate was 68% and 96% respectively, with topical NSAIDs. This study has shown topical NSAIDs to be safe, effective, rapid and acceptable mode of treatment for cyclical and non-cyclical mastalgia.

  3. Tamoxifen-loaded liposomal topical formulation arrests hair growth in mice.

    PubMed

    Bhatia, A; Singh, B; Amarji, B; Katare, O P

    2010-08-01

    For several decades, androgens have dominated endocrine research in the domain of hair growth control. However, it has long been known that oestrogens also tend to alter hair follicle (HF) growth and cycling significantly by binding to locally expressed high-affinity oestrogen receptors (ORs). Tamoxifen (TAM) is a selective OR modulator. The current work aims to investigate the effect of topically applied TAM on the hair growth of mice. Test formulations were applied once daily on the shaved back area of the mice for a period of 5 weeks. The effect of these formulations was studied by visual and histological examinations. Animals treated with saline and placebo gel formulation showed significant hair growth on the 20th day. The number and length of follicles were also found to be normal. In contrast, no hair growth was observed in the animals treated with TAM gel, even after the termination of treatment. The HFs were found to be arrested in telogen phase with clear signs of follicle dystrophy. The hair growth-retarding effect of TAM observed in the current study clearly demonstrates its OR agonistic effect on hair growth. This work also provides a distinct lead towards the possible potential of TAM liposomal gel in the treatment of hirsutism.

  4. GEM printer: 3D gel printer for free shaping of functional gel engineering materials

    NASA Astrophysics Data System (ADS)

    Furukawa, Hidemitsu; Muroi, Hisato; Yamamoto, Kouki; Serizawa, Ryo; Gong, Jin

    2013-04-01

    In the past decade, several high-strength gels have been developed. These gels are expected to use as a kind of new engineering materials in the fields of industry and medical as substitutes to polyester fibers, which are materials of artificial blood vessels. The gels have both low surface friction and well permeability due to a large amount of water absorbed in the gels, which are superiority of the gels compering to the polyester fibers. It is, however, difficult for gels to be forked structure or cavity structure by using cutting or mold. Consequently, it is necessary to develop the additive manufacturing device to synthesize and mode freely gels at the same time. Here we try to develop an optical 3D gel printer that enables gels to be shaped precisely and freely. For the free forming of high-strength gels, the 1st gels are ground to particles and mixed with 2nd pregel solution, and the mixed solution is gelled by the irradiation of UV laser beam through an optical fiber. The use of the optical fiber makes one-point UV irradiation possible. Since the optical fiber is controlled by 3D-CAD, the precise and free molding in XYZ directions is easily realized. We successfully synthesized tough gels using the gel printer.

  5. Ocular penetration of topical antibiotics: study on the penetration of chloramphenicol, tobramycin and netilmicin into the anterior chamber after topical administration.

    PubMed

    Cagini, Carlo; Piccinelli, Francesco; Lupidi, Marco; Messina, Marco; Cerquaglia, Alessio; Cerqualglia, Alessio; Manes, Silvia; Fiore, Tito; Pellegrino, Roberto M

    2013-01-01

    To compare penetration in the aqueous humour of topically applied antibiotics. Randomized prospective study, Department of Ophthalmology, University of Perugia, Italy Patients undergoing cataract surgery. One hundred twenty-two patients were included: 14 received one drop of chloramphenicol suspension; 12 one application of chloramphenicol gel; 11 one drop of netilmicin suspension; 13 one drop of tobramycin suspension; 37 repeated instillations of chloramphenicol suspension every 10 min for a total of four drops; and 35 repeated instillations of chloramphenicol gel every 10 min for a total of four drops. Samples were taken immediately before surgery from the anterior chamber in order to determine the antibiotic by means of high-performance liquid chromatography. Samples were taken 45-190 min after the eye drops were instilled. Intraocular penetration of chloramphenicol, netilmicin and tobramicyn. After a single administration, netilmicin and tobramycin were undetectable, whereas the chloramphenicol suspension reached a mean concentration of 0.23 ± 0.21 μg/mL, and the chloramphenicol gel a mean concentration of 0.13 ± 0.14 μg/mL. After repeated administrations, the mean concentrations of the chloramphenicol suspension and gel were 0.60 ± 0.26 μg/mL and 0.58 ± 0.18 μg/mL, respectively. Tobramycin and netilmicin do not reach detectable concentrations, whereas chloramphenicol, after multiple administrations, reaches concentrations that are effective against Haemophilus influenzae and Haemophilus parainfluenzae, Legionella pneumophila, Moraxella catarrhalis, Neisseria meningitidis, Pasteurella multocida and Streptococcus pneumoniae. This means that chloramphenicol can be rationally used in the prophylaxis and treatment of infections supported by sensitive germs. © 2013 The Authors. Clinical and Experimental Ophthalmology © 2013 Royal Australian and New Zealand College of Ophthalmologists.

  6. Adherence and acceptability in MTN 001: A randomized cross-over trial of daily oral and topical tenofovir for HIV prevention in women

    PubMed Central

    Minnis, Alexandra M.; Gandham, Sharavi; Richardson, Barbra A.; Guddera, Vijayanand; Chen, Beatrice A.; Salata, Robert; Nakabiito, Clemensia; Hoesley, Craig; Justman, Jessica; Soto-Torres, Lydia; Patterson, Karen; Gomez, Kailazarid; Hendrix, Craig

    2012-01-01

    We compared adherence to and acceptability of daily topical and oral formulations of tenofovir (TFV) used as pre-exposure prophylaxis (PrEP) for HIV prevention among women in South Africa, Uganda and the United States. 144 sexually active, HIV-uninfected women participated in a cross-over study of three regimens: oral tablet, vaginal gel, or both. We tested for differences in adherence and evaluated product acceptability. Self-reported adherence for all regimens was high (94%), but serum TFV concentrations indicated only 64% of participants used tablets consistently. Most women in the U.S. (72%) favored tablets over gel; while preferences varied at the African sites (42% preferred gel and 40% tablets). Findings indicate a role for oral and vaginal PrEP formulations and highlight the importance of integrating pharmacokinetics-based adherence assessment in future trials. Biomedical HIV prevention interventions should consider geographic and cultural experience with product formulations, partner involvement, and sexual health benefits that ultimately influence use. PMID:23065145

  7. Topical use of sodium cromoglicate (cromolyn sodium) to treat atopic dermatitis and other skin allergies.

    PubMed

    Zur, Eyal

    2012-01-01

    Sodium cromoglicate (cromolyn sodium) is a very well-known medicine that has been used for many years for various allergic conditions. The topical use of this medicine is less known, and there are no commercial medicines of cream, gel, or lotion in most of the world. This article summarizes the clinical data accumulated from seventeen trials that checked the topical efficacy and safety of sodium cromoglicate and analyzes the clinical implementations of this medicine in the topical treatment of atopic dermatitis and other skin allergies. In addition, this article analyzes the various formulations that have been used in the clinical trials in an attempt to find the optimal formulation. The topical use of sodium cromoglicate seemed to have a promising potential, and implementing the data of this article can allow the compounding pharmacist a very interesting professional activity in very common and widespread allergic pathologies.

  8. The Effect of Preventive Agents (Mouthwashes/Gels) on the Color Stability of Dental Resin-Based Composite Materials

    PubMed Central

    Al-Samadani, Khalid H.

    2017-01-01

    The color of dental restorative material should be maintained throughout its functional lifetime in an oral environment. However, the frequent use of mouthwash may affect the color stability of these composite restorations. The aim of this study is to assess the effects of using various mouthwashes on the color stability of various dental restorative composite materials. For this purpose, four mouthwashes/gels (Flocare gel (0.4% stannous fluoride), Pascal gel (topical APF fluoride), Pro-Relief mouthwash (sodium fluoride), and Plax Soin mouthwash (sodium fluoride)), and distilled water as a control, were selected. These were divided into five groups: Group 1: Flocare gel; Group 2: Pascal gel; Group 3: Pro-Relief mouthwash; Group 4: Plax Soin mouthwash; and Group 5: distilled water (control). Prepared restorative materials samples were immersed in the groups of mouthwashes/gels and the distilled water (control) for 24, 48, and 72 h. The discoloration that all materials exhibited with all immersion groups was significantly different at each of the three time periods for all groups (p < 0.05). Results from immersion in Flocare gel, Pascal gel, Pro-Relief mouthwash, and Plax Soin mouthwash were statistically significant (p < 0.05). The color change chroma was not significant for Pro-Relief and Plax Soin mouthwash (p > 0.05). Mouthwashes/gels affect color shifting for all composite resin materials, and changes are exaggerated over time. However, discoloration effects are not perceptible to the human eye. PMID:29563424

  9. Evaluation of mechanical and rheological properties of metronidazole gel as local delivery system.

    PubMed

    Jelvehgari, Mitra; Montazam, Hassan

    2011-06-01

    Rosacea is a chronic multifactorial vascular skin disorder that affects about 10 percent of the general population. Metronidazole is an effective antibiotic in the treatment of moderate-to severe rosacea. Metronidazole is a suitable drug in cases of resistance to tetracycline or erythromycin, but it has also been shown that oral metronidazole may increase the side effects (e.g., peripheral neuropathy). Oral metronidazole should not be used for more than three months, and hence topical metronidazole gel is the best therapeutic choice in rosacea (especially during pregnancy). This study examined the mechanical (adhesiveness, cohesiveness, extrudability, spreadability, homogeneity) and rheological (viscosity), skin irritant and drug release properties of different metronidazole gel formulations that contain anionic emulsifying wax, glycerin and lactic acid in different proportions. The release studies were conducted using Franz diffusion cells and Silastic membrane as a barrier. The results indicated that gel compressibility, hardness, and adhesiveness, are the factors that influence the ease of gel removal from the container, ease of gel application onto the mucosal membrane, and gel bioadhesion. The findings showed that there exists a strong negative correlation between the spreadability of a formulation and its cohesiveness, the spreadability of a formulation is inversely proportional to its cohesiveness. However, sorbitol solution (70%) concentration was not significantly correlated with drug release. In addition, drug release was significantly reduced as the concentration of anionic emulsifying wax increased and the concentration of lactic acid decreased. The maximum metronidazole release was achieved at a pH of 4-6. Data obtained from in vitro release studies were fitted to various kinetic models and high correlation was obtained in the Higuchi and first order models. The results showed that all the gel formulations showed good extrudability, viscosity

  10. Polymer architecture of magnetic gels: a review

    NASA Astrophysics Data System (ADS)

    Weeber, Rudolf; Hermes, Melissa; Schmidt, Annette M.; Holm, Christian

    2018-02-01

    In this review article, we provide an introduction to ferrogels, i.e. polymeric gels with embedded magnetic particles. Due to the interplay between magnetic and elastic properties of these materials, they are promising candidates for engineering and biomedical applications such as actuation and controlled drug release. Particular emphasis will be put on the polymer architecture of magnetic gels since it controls the degrees of freedom of the magnetic particles in the gel, and it is important for the particle-polymer coupling determining the mechanisms available for the gel deformation in magnetic fields. We report on the different polymer architectures that have been realized so far, and provide an overview of synthesis strategies and experimental techniques for the characterization of these materials. We further focus on theoretical and simulational studies carried out on magnetic gels, and highlight their contributions towards understanding the influence of the gels’ polymer architecture.

  11. Sodium Lauryl Sulfate Increases the Efficacy of a Topical Formulation of Foscarnet against Herpes Simplex Virus Type 1 Cutaneous Lesions in Mice

    PubMed Central

    Piret, Jocelyne; Désormeaux, André; Cormier, Hélène; Lamontagne, Julie; Gourde, Pierrette; Juhász, Julianna; Bergeron, Michel G.

    2000-01-01

    The influence of sodium lauryl sulfate (SLS) on the efficacies of topical gel formulations of foscarnet against herpes simplex virus type 1 (HSV-1) cutaneous infection has been evaluated in mice. A single application of the gel formulation containing 3% foscarnet given 24 h postinfection exerted only a modest effect on the development of herpetic skin lesions. Of prime interest, the addition of 5% SLS to this gel formulation markedly reduced the mean lesion score. The improved efficacy of the foscarnet formulation containing SLS could be attributed to an increased penetration of the antiviral agent into the epidermis. In vitro, SLS decreased in a concentration-dependent manner the infectivities of herpesviruses for Vero cells. SLS also inhibited the HSV-1 strain F-induced cytopathic effect. Combinations of foscarnet and SLS resulted in subsynergistic to subantagonistic effects, depending on the concentration used. Foscarnet in phosphate-buffered saline decreased in a dose-dependent manner the viability of cultured human skin fibroblasts. This toxic effect was markedly decreased when foscarnet was incorporated into the polymer matrix. The presence of SLS in the gel formulations did not alter the viabilities of these cells. The use of gel formulations containing foscarnet and SLS could represent an attractive approach to the treatment of herpetic mucocutaneous lesions, especially those caused by acyclovir-resistant strains. PMID:10952566

  12. Development of gel materials with high transparency and mechanical strength for use with a 3D gel printer SWIM-ER

    NASA Astrophysics Data System (ADS)

    Tase, Taishi; Okada, Koji; Takamatsu, Kyuichiro; Saito, Azusa; Kawakami, Masaru; Furukawa, Hidemitsu

    2016-04-01

    Medical doctors use artificial blood vessels and organ models, which are usually made of plastic, to explain operations to students, or patients awaiting treatment. However, there are some problems such as the high cost of making the model and there is not a realistic feel because the model is hard. These problems can be solved using soft and wet material for instance gel. Gels are materials with unique properties such as transparency, biocompatibility, and low friction. In recent years, high strength gel has been developed and is expected to be applied in medical fields in the future. Artificial models of gel can be produced by 3D gel printers. Our group has been developing a 3D gel printer with 1mm precision in printing, but the shape, size and mechanical strength are not sufficient for medical models. In this study, we overcome these problems and make a gel model which is transparent, mechanically strong with a fine shape. The strength and molding accuracy is improved by changing and preparing the cross linker and ultraviolet absorber. We conducted mechanical and molding tests to confirm that the gel material properties improved.

  13. An Open-Label, Multi-Center, Multiple-Application Pharmacokinetic Study of Naftifine HCl Gel 2% in Pediatric Subjects With Tinea Pedis.

    PubMed

    Verma, Amit; Olayinka, Babajide; Fleischer, Alan B

    2015-07-01

    Tinea pedis is the most common superficial fungal infection. Naftifine hydrochloride is a topical antifungal of the allylamine class, displaying fungicidal activity and clinically significant anti-bacterial and anti-inflammatory effects. Clinical data on topical antifungal therapy using naftifine for tinea pedis in a pediatric population is limited. To assess trends in efficacy, tolerability, safety, and to quantify the pharmacokinetics (PK) of topical naftifine hydrochloride gel 2% in pediatric subjects with tinea pedis. Twenty-eight subjects (22 pediatric and 6 adult controls) were enrolled and treated in the study. Approximately 2 grams of naftifine hydrochloride gel 2% was applied to each foot (4 grams total) for subjects with tinea pedis. Pharmacokinetic blood and urine samples were collected at various time points throughout the study. Efficacy was assessed based on potassium hydroxide, dermatophyte culture, and signs and symptom results at days 7, 14, and 28. Adverse event information was collected routinely.
    The rate and extent of systemic exposure among the pediatric and adult control subjects was low. Adverse events were minimal and were not related to treatment. Positive results were observed as early as day 7; however the proportion of subjects achieving success generally increased over time through day 28 in both treatment groups. Naftifine hydrochloride gel 2% was found to be well tolerated and safe. Trends in clinical benefit were observed throughout the treatment period; however, continued improvement in efficacy rates were observed during the post-treatment period.

  14. Efficacy and safety of diclofenac diethylamine 1.16% gel in acute neck pain: a randomized, double-blind, placebo-controlled study

    PubMed Central

    2013-01-01

    Background Neck pain (NP) is a common musculoskeletal disorder in primary care that frequently causes discomfort. Non-steroidal anti-inflammatory drugs (NSAIDs) may be used to reduce neck pain and associated inflammation and facilitate earlier recovery. Topical diclofenac diethylamine (DDEA) 1.16% gel is clinically proven to be effective and well tolerated in acute and chronic musculoskeletal conditions, but until now no clinical data existed for its use in acute NP. The aim of this study was to assess the efficacy and safety of DDEA 1.16% gel compared with placebo gel in acute NP. Methods In a randomized, double-blind, placebo-controlled study, patients with acute NP (n = 72) were treated with DDEA 1.16% gel (2 g, 4x/day, for 5 days) or placebo. Efficacy assessments included pain-on-movement (POM), pain-at-rest (PAR), functional neck disability index (NDI) and response to treatment (decrease in POM by 50% after 48 h). Adverse events (AEs) were recorded throughout the study. Results The primary outcome, POM at 48 h, was statistically significantly lower with DDEA gel (19.5 mm) vs. placebo (56.9 mm) (p < 0.0001), representing a clinically relevant decrease from baseline (75% vs. 23%, respectively). All POM scores were significantly lower with DDEA gel vs. placebo from 1 h, as were PAR and NDI scores from first assessment (24 h) onwards (all p < 0.0001). Response to treatment was significantly higher with DDEA gel (94.4%) vs. placebo (8.3%) (p < 0.0001). There were no AEs with DDEA gel. Conclusions DDEA 1.16% gel, which is available over-the-counter, was effective and well tolerated in the treatment of acute neck pain. The tools used to assess efficacy suggest that it quickly reduced neck pain and improved neck function. However, questions remain regarding the comparability and validity of such tools. Further studies will help ascertain whether DDEA 1.16% gel offers an alternative treatment option in this common, often debilitating condition

  15. Moisturizing potentials of ascorbyl palmitate and calcium ascorbate in various topical formulations.

    PubMed

    Gönüllü, U; Yener, G; Uner, M; Incegül, T

    2004-02-01

    The aim of this study was to use two of Vitamin C derivatives, lipophilic ascorbyl palmitate and hydrophilic calcium ascorbate to determine their skin-hydrating effects for the first time. For this purpose, anhydrous cream, gel and w/o emulsion were prepared and applied to the volunteers' inner forearms. A commercial topical preparation containing a known moisturizer, Vitamin E, was also chosen and used for comparison. Moisture contents of the skin were measured by using corneometer.

  16. Topical chlorophyll-pheophytin derivative-mediated photodynamic therapy for DMBA-induced hamster buccal pouch premaligant lesions: an in vivo study

    NASA Astrophysics Data System (ADS)

    Hsu, Yih-Chih; Chiang, Chung-Pin; Chen, Jian Wen; Lee, Jeng-Woei; How, Mon-Hsin

    2010-02-01

    In Taiwan, oral cancer has become a prominent cancer because of its highest annual increase rate among all cancer diseases. Betel quid chewing habit is a major risk factor for oral precancerous and cancerous lesions and there are more than two million people who have this habit in Taiwan. Our previous studies showed that chlorophyll-pheophytin derivative (CPD)-mediated PDT is very effective for killing of SCC-4 cell lines in vitro. In order to decrease the systemic phototoxic effect of CPD, this study was designed to use a topical CPD-mediated PDT for treatment of DMBA-induced hamster buccal pouch precancerous lesions. DMBA was applied to one of the buccal pouches of hamsters thrice a week for 8 to 10 weeks. Precancerous lesions of moderate to severe dysplasia were induced and proven by histological examination. These induced precancerous lesions were used for testing the efficacy of topical CPD-mediated PDT. Before PDT, fluorescence spectroscopy was used to determine when CPD reached its peak level in the lesional epithelial cells after topical application of CPD gel. We found that CPD reached its peak level in precancerous lesions about 1 hour (range, 0 to 30 hours) after topical application of CPD gel. The precancerous lesions in hamsters were then treated with topical CPD-mediated PDT (fluence rate: 200 mW/cm2; light exposure dose 100 J/cm2) using the portable WonderLight LED 635 nm fiber-guided light device once or twice a week. Visual and histological examination demonstrated that topical CPD-mediated PDT was partially effective treatment modality for DMBA-induced hamster buccal pouch precancerous lesions.

  17. Update on the management of rosacea: a status report on the current role and new horizons with topical azelaic acid.

    PubMed

    Del Rosso, James Q; Kircik, Leon H

    2014-12-01

    Azelaic acid (AzA) 15% gel has been available in the United States for slightly over a decade, approved for treatment of the inflammatory lesions (papules and pustules) of rosacea. Efficacy and safety have been established in multiple studies both as monotherapy and in combination with oral doxycycline. Azelaic acid 15% gel has been shown not to induce epidermal permeability barrier impairment, and proper skin care reduces the likelihood of neurosensory adverse effects of stinging and burning that can affect a subset of patients with rosacea. Azelaic acid 15% gel appears to produce a quicker onset of clinical effect than metronidazole in some patients when either agent is used in combination with subantimicrobial dose doxycycline; however, both topical agents are effective when used in this combination approach for papulopustular rosacea (PPR). Although more information is needed on the modes of action of AzA in the treatment of rosacea, downregulation of the cathelicidin pathway appears to be one operative mode of action based on in vitro and in vivo studies, including data from patients treated with AzA 15% gel for PPR. Azelaic acid 15% foam is currently in the latter stages of development for PPR, with pivotal studies demonstrating efficacy and favorable tolerability, including a very low incidence of stinging, burning, and itching even without the use of designated skin care products.

  18. A zwitterionic gel electrolyte for efficient solid-state supercapacitors

    PubMed Central

    Peng, Xu; Liu, Huili; Yin, Qin; Wu, Junchi; Chen, Pengzuo; Zhang, Guangzhao; Liu, Guangming; Wu, Changzheng; Xie, Yi

    2016-01-01

    Gel electrolytes have attracted increasing attention for solid-state supercapacitors. An ideal gel electrolyte usually requires a combination of advantages of high ion migration rate, reasonable mechanical strength and robust water retention ability at the solid state for ensuring excellent work durability. Here we report a zwitterionic gel electrolyte that successfully brings the synergic advantages of robust water retention ability and ion migration channels, manifesting in superior electrochemical performance. When applying the zwitterionic gel electrolyte, our graphene-based solid-state supercapacitor reaches a volume capacitance of 300.8 F cm−3 at 0.8 A cm−3 with a rate capacity of only 14.9% capacitance loss as the current density increases from 0.8 to 20 A cm−3, representing the best value among the previously reported graphene-based solid-state supercapacitors, to the best of our knowledge. We anticipate that zwitterionic gel electrolyte may be developed as a gel electrolyte in solid-state supercapacitors. PMID:27225484

  19. Preparation and evaluation of miconazole nitrate-loaded solid lipid nanoparticles for topical delivery.

    PubMed

    Bhalekar, Mangesh R; Pokharkar, Varsha; Madgulkar, Ashwini; Patil, Nilam; Patil, Nilkanth

    2009-01-01

    The purpose of this study was to prepare miconazole nitrate (MN) loaded solid lipid nanoparticles (MN-SLN) effective for topical delivery of miconazole nitrate. Compritol 888 ATO as lipid, propylene glycol (PG) to increase drug solubility in lipid, tween 80, and glyceryl monostearate were used as the surfactants to stabilize SLN dispersion in the SLN preparation using hot homogenization method. SLN dispersions exhibited average size between 244 and 766 nm. All the dispersions had high entrapment efficiency ranging from 80% to 100%. The MN-SLN dispersion which showed good stability for a period of 1 month was selected. This MN-SLN was characterized for particle size, entrapment efficiency, and X-ray diffraction. The penetration of miconazole nitrate from the gel formulated using selected MN-SLN dispersion as into cadaver skins was evaluated ex-vivo using franz diffusion cell. The results of differential scanning calorimetry (DSC) showed that MN was dispersed in SLN in an amorphous state. The MN-SLN formulations could significantly increase the accumulative uptake of MN in skin over the marketed gel and showed a significantly enhanced skin targeting effect. These results indicate that the studied MN-SLN formulation with skin targeting may be a promising carrier for topical delivery of miconazole nitrate.

  20. Role of topical tranexamic acid in the management of idiopathic anterior epistaxis in adult patients in the emergency department.

    PubMed

    Logan, Jill K; Pantle, Hardin

    2016-11-01

    The role of topical tranexamic acid in the management of anterior epistaxis in adult patients in the emergency department (ED) is examined. The use of alternative agents for the treatment of epistaxis before the use of nasal packing may be reasonable due to patient discomfort, potential complications, and the need for follow-up with a healthcare provider for packing removal. One such agent is tranexamic acid. Two published studies evaluated the off-label use of topical tranexamic acid for the treatment of epistaxis. The first trial compared the efficacy of a topical gel containing 10% tranexamic acid with a placebo gel containing glycerin for the treatment of epistaxis. The percentage of patients whose bleeding ceased within 30 minutes of the intervention did not significantly differ between the tranexamic acid and placebo groups (p = 0.16). The second trial compared the efficacy of cotton pledgets soaked in the i.v. formulation of tranexamic acid inserted into the bleeding naris with standard nasal packing therapy. Bleeding cessation occurred within 10 minutes in 71% of the tranexamic acid group versus 31.2% of the standard treatment group (odds ratio, 2.28; 95% confidence interval, 1.68-3.09; p < 0.001). Additional information is necessary to fully evaluate the role of topical tranexamic acid in treatment algorithms; however, the use of topical tranexamic acid may be beneficial in select populations. Topical tranexamic acid may have a role in the treatment of anterior epistaxis in select ED patients, though additional studies are needed to confirm its role in treatment algorithms. Copyright © 2016 by the American Society of Health-System Pharmacists, Inc. All rights reserved.

  1. Dopamine transporter-dependent and -independent striatal binding of the benztropine analog JHW 007, a cocaine antagonist with low abuse liability

    USDA-ARS?s Scientific Manuscript database

    The benztropine analog JHW 007 displays high affinity for the dopamine transporter (DAT), but unlike typical DAT ligands, has relatively low abuse liability and blocks effects of cocaine,including its self-administration. To determine sites responsible for the cocaine-antagonist effects of JHW 007, ...

  2. Topical rosacea therapy: the importance of vehicles for efficacy, tolerability and compliance.

    PubMed

    Jackson, J Mark; Pelle, Michelle

    2011-06-01

    Many topical medications are available for the treatment of papulopustular rosacea. While treatments contain metronidazole, azelaic acid, or sodium sulfacetamide-sulfur as the active ingredient, the composition of the vehicle formulations varies widely. These vehicles come in gels, creams, lotions and foams; some ingredients are common to many vehicles, while some vehicles contain unique ingredients designed to optimize skin penetration and delivery of the active drug to its target. Vehicles can also influence tolerability, which is always a concern in patients with heightened skin sensitivity, and compliance, which is typically lower for topical treatments than oral treatments. Ideally, the vehicle of any rosacea treatment should enhance drug delivery, be nonirritating and be easy to use. Ingredients that help repair barrier function are also desirable. This review will focus on the key components of the vehicles from the most commonly used topical therapies for papulopustular rosacea and how vehicle formulations influence the delivery of active ingredient, skin barrier repair, tolerability and compliance.

  3. A Simple Vertical Slab Gel Electrophoresis Apparatus.

    ERIC Educational Resources Information Center

    Carter, J. B.; And Others

    1983-01-01

    Describes an inexpensive, easily constructed, and safe vertical slab gel kit used routinely for sodium dodecyl sulphate-polyacrylamide gel electrophoresis research and student experiments. Five kits are run from a single transformer. Because toxic solutions are used, students are given plastic gloves and closely supervised during laboratory…

  4. Evaluation of inositol phosphates in urine after topical administration of myo-inositol hexaphosphate to female Wistar rats.

    PubMed

    Grases, F; Costa-Bauzá, A; Berga, F; Rodríguez, A; Gomila, R M; Martorell, G; Martínez-Cignoni, M R

    2018-01-01

    Previous studies demonstrated a remarkable increase of urinary InsP 6 by topical administration. However, the methodology used for InsP 6 analysis was not specific. The aim of this paper is to measure urinary inositol phosphates InsPs using more advanced methodologies and to compare the results with those obtained by the non-specific method. We fed 12 female rats with a diet without InsP 6 for 16days. Then, we administered a topical InsP 6 gel at high doses for 7days (50mgInsP 6 /day) or at low doses for 28days (20mgInsP 6 /day). We measured urine levels InsPs using a nonspecific method (based on the ability of InsPs to complex Al 3+ ) and levels of InsP 6 by a specific method (using polyacrylamide gel electrophoresis). Identification of different InsPs was performed by MS. At baseline, after dietary deprivation of InsP 6 , rats only excreted InsP 2 in their urine, and there was no detectable InsP 6 or other InsPs. Rats given the high dose treatment for 7days had abundant urinary InsP 6 , but also had other InsPs in their urine; cessation of InsP 6 administration led to decreased levels of urinary InsPs. Rats given the low dose treatment for 28days had increasing levels of urinary InsPs over time. The maximum urinary InsP 6 was at 21days, after which InsPs excretion decreased. We conclude that the skin can absorb InsP 6 from a topical gel, and that InsP 6 is excreted in the urine, along with other InsPs (InsP 5 , InsP 4 , InsP 3 , and InsP 2 ). Copyright © 2017 Elsevier Inc. All rights reserved.

  5. Transforming growth factor-β (TGF-β) activation in cutaneous wounds after topical application of aloe vera gel.

    PubMed

    Takzaree, Nasrin; Hadjiakhondi, Abbas; Hassanzadeh, Gholamreza; Rouini, Mohammad Reza; Manayi, Azadeh; Zolbin, Masoumeh Majidi

    2016-12-01

    Aloe vera is a medicinal plant used to treat various skin diseases. The effects of using aloe vera gel on the healing process were investigated by microscopic methods, cell counting, and TGF-β gene expression in the wound bed. Sixty Wistar rats weighing 200-250 g were placed under anesthesia in sterile conditions. A square 1.5 cm × 1.5 cm wound was made on the back of the neck. The rats were divided into control and 2 experimental groups. Additionally, the control and experimental groups were separated into 3 subgroups corresponding to 4, 7, and 14 days of study. In the first experimental group, aloe vera was used twice on the wound. The second experimental group received aloe vera overtreatment once on the wound. The positive control group received daily application of 1% phenytoein cream following surgical wound creation. The control group did not receive any treatment. This tissue was examined using histological staining (H&E) and Masson's Trichrome. Wound surface and wound healing were evaluated separately. TGF-β gene expression was analyzed by RT-PCR. Results showed that fibroblasts in both experimental groups were significantly increased, thereby acceleration wound healing. Application of aloe vera gel will increase TGF-β gene expression, ultimately accelerating the wound healing process.

  6. Development of MGD007, a gpA33 x CD3 bispecific DART® protein for T-cell immunotherapy of metastatic colorectal cancer.

    PubMed

    Moore, Paul A; Shah, Kalpana; Yang, Yinhua; Alderson, Ralph; Roberts, Penny; Long, Vatana; Liu, Daorong; Li, Jonathan C; Burke, Steve; Ciccarone, Valentina; Li, Hua; Fieger, Claudia B; Hooley, Jeff; Easton, Ann; Licea, Monica; Gorlatov, Sergey; King, Kathleen L; Young, Peter; Adami, Arash; Loo, Deryk; Chichili, Gurunadh R; Liu, Liqin; Smith, Douglas H; Brown, Jennifer G; Chen, Francine Z; Koenig, Scott; Mather, Jennie; Bonvini, Ezio; Johnson, Syd

    2018-06-04

    We have developed MGD007 (anti-glycoprotein A33 x anti-CD3), a DART® protein designed to redirect T-cells to target gpA33 expressing colon cancer. The gpA33 target was selected based on an antibody-based screen to identify cancer antigens universally expressed in both primary and metastatic CRC specimens, including putative cancer stem cell populations. MGD007 displays the anticipated bispecific binding properties and mediates potent lysis of gpA33-positive cancer cell lines, including models of colorectal cancer stem cells, through recruitment of T-cells. Xenograft studies showed tumor growth inhibition at doses as low as 4 µg/kg. Both CD8 and CD4 T cells mediated lysis of gpA33-expressing tumor cells, with activity accompanied by increases in granzyme and perforin. Notably, suppressive T-cell populations could also be leveraged to mediate lysis of gpA33 expressing tumor cells. Concomitant with CTL activity, both T-cell activation and expansion are observed in a gpA33-dependent manner. No cytokine activation was observed with human PBMC alone, consistent with the absence of gpA33 expression on peripheral blood cell populations. Following prolonged exposure to MGD007 and gpA33 positive tumor cells, T cells express PD 1 and LAG-3 and acquire a memory phenotype but retain ability to support potent cell killing. In cynomolgus monkeys, 4 weekly doses of 100 µg/kg were well tolerated, with prolonged PK consistent with that of an Fc-containing molecule. Taken together MGD007 displays potent activity against colorectal cancer cells consistent with a mechanism of action endowed in its design and support further investigation of MGD007 as a potential novel therapeutic treatment for colorectal cancer. Copyright ©2018, American Association for Cancer Research.

  7. Bleach Gel: A Simple Agarose Gel for Analyzing RNA Quality

    PubMed Central

    Aranda, Patrick S.; LaJoie, Dollie M.; Jorcyk, Cheryl L.

    2013-01-01

    RNA-based applications requiring high quality, non-degraded RNA are a foundational element of many research studies. As such, it is paramount that the integrity of experimental RNA is validated prior to cDNA synthesis or other downstream applications. In the absence of expensive equipment such as microfluidic electrophoretic devices, and as an alternative to the costly and time-consuming standard formaldehyde gel, RNA quality can be quickly analyzed by adding small amounts of commercial bleach to TAE buffer-based agarose gels prior to electrophoresis. In the presence of low concentrations of bleach, the secondary structure of RNA is denatured and potential contaminating RNases are destroyed. Because of this, the ‘bleach gel’ is a functional approach that addresses the need for an inexpensive and safe way to evaluate RNA integrity and will improve the ability of researchers to rapidly analyze RNA quality. PMID:22222980

  8. Characterization of Lentinus edodes β-glucan influencing the in vitro starch digestibility of wheat starch gel.

    PubMed

    Zhuang, Haining; Chen, Zhongqiu; Feng, Tao; Yang, Yan; Zhang, Jingsong; Liu, Guodong; Li, Zhaofeng; Ye, Ran

    2017-06-01

    Lentinus edodes β-glucan (abbreviated LEBG) was prepared from fruiting bodies of Lentinus edodes. The average molecular weight (Mw) and polydispersity index (Mw/Mn) of LEBG were measured to be 1.868×10 6 g/mol and 1.007, respectively. In addition, the monosaccharide composition of LEBG was composed of arabinose, galactose, glucose, xylose, mannose with a molar ratio of 5:11:18:644:16. After adding LEBG, both G' and G″ of starch gel increased. This is mainly because the connecting points between the molecular chains of LEBG and starch formed so that gel network structures were enhanced. The peak temperature in the heat flow diagram shifted to a higher temperature and the peak area of the endothermic enthalpy increased. Furthermore, LEBG can significantly inhibit starch hydrolysis. The predicted glycemic index (pGI) values were reduced when starch was replaced with LEBG at 20% (w/w). It might indicate that LEBG was suitable to develop low GI noodle or bread. Copyright © 2016 Elsevier Ltd. All rights reserved.

  9. Development and evaluation of ultra-small nanostructured lipid carriers: novel topical delivery system for athlete's foot.

    PubMed

    Singh, Samipta; Singh, Mahendra; Tripathi, Chandra Bhushan; Arya, Malti; Saraf, Shubhini A

    2016-02-01

    Athlete's foot is a fungal infection of the foot which causes dry, itchy, flaky condition of the skin caused by Trichophyton species. In this study, the potential of ultra-small nanostructured lipid carrier (usNLC)-based topical gel of miconazole nitrate for the treatment of athlete's foot was evaluated. Nanostructure lipid carriers (NLCs) prepared by melt emulsification and sonication technique were characterized for particle size, drug entrapment, zeta potential and drug release. The optimized usNLC revealed particle size 53.79 nm, entrapment efficiency 86.77%, zeta potential -12.9 mV and polydispersity index (PDI) of 0.27. The drug release studies of usNLC showed initial fast release followed by sustained release with 91.99% drug released in 24 h. Optimized usNLCs were incorporated into carbopol-934 gel and evaluated for pH (6.8), viscosity (36,400 mPa s) and texture analysis. Antifungal activity against Trichophyton mentagrophytes exhibited wider zone of inhibition, 6.6 ± 1.5 mm for optimized usNLC3 gel viz-à-viz marketed gel formulation (3.7 ± 1.2 mm). Hen's egg test-chorioallantoic membrane (HET-CAM) irritation test confirmed optimized usNLC gel to be non-irritant to chorioallantoic membrane. Improved dermal delivery of miconazole by usNLC gel could be achieved for treatment of athlete's foot.

  10. Sucrose ester stabilized solid lipid nanoparticles and nanostructured lipid carriers. II. Evaluation of the imidazole antifungal drug-loaded nanoparticle dispersions and their gel formulations.

    PubMed

    Das, Surajit; Ng, Wai Kiong; Tan, Reginald B H

    2014-03-14

    This study focused on: (i) feasibility of the previously developed sucrose ester stabilized SLNs and NLCs to encapsulate different imidazole antifungal drugs and (ii) preparation and evaluation of topical gel formulations of those SLNs and NLCs. Three imidazole antifungal drugs; clotrimazole, ketoconazole and climbazole were selected for this study. The results suggested that size, size distribution and drug encapsulation efficiency depend on the drug molecule and type of nanoparticles (SLN/NLC). The drug release experiment always showed faster drug release from NLCs than SLNs when the same drug molecule was loaded in both nanoparticles. However, drug release rate from both SLNs and NLCs followed the order of climbazole > ketoconazole > clotrimazole. NLCs demonstrated better physicochemical stability than SLNs in the case of all drugs. The drug release rate from ketoconazole- and clotrimazole-loaded SLNs became faster after three months than a fresh formulation. There was no significant change in drug release rate from climbazole-loaded SLNs and all drug-loaded NLCs. Gel formulations of SLNs and NLCs were prepared using polycarbophil polymer. Continuous flow measurements demonstrated non-Newtonian flow with shear-thinning behavior and thixotropy. Oscillation measurements depicted viscoelasticity of the gel formulations. Similar to nanoparticle dispersion, drug release rate from SLN- and NLC-gel was in the order of climbazole > ketoconazole > clotrimazole. However, significantly slower drug release was noticed from all gel formulations than their nanoparticle counterparts. Unlike nanoparticle dispersions, no significant difference in drug release from gel formulations containing SLNs and NLCs was observed for each drug. This study concludes that gel formulation of imidazole drug-loaded SLNs and NLCs can be used for sustained/prolonged topical delivery of the drugs.

  11. Oxybutynin Topical

    MedlinePlus

    ... treatment with oxybutynin gel.Oxybutynin gel may catch fire. Stay away from open flames and do not ... This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

  12. Assessment of topical microbicides to prevent HIV-1 transmission: concepts, testing, lessons learned.

    PubMed

    Friend, David R; Kiser, Patrick F

    2013-09-01

    The development of topically applied products capable of preventing vaginal and rectal transmission of HIV-1 has been on-going for nearly 20 years. Despite this, only one clinical trial has demonstrated protection against sexual transmission of HIV-1 in women. This review covers the development of microbicides, also referred to as topical pre-exposure prophylaxis (PrEP), through three stages. The first stage focused on nonspecific agents, including surfactants such as nonoxynol-9 (N-9), to prevent HIV-1 transmission. Unfortunately, N-9 enhanced susceptibility to sexual transmission of HIV-1 when evaluated for efficacy. Soon thereafter, other nonspecific agents (polyanions) were quickly moved into large efficacy trials. Due to a lack of coordination among investigators and funders, a large investment was made in a class of compounds shown ultimately to be ineffective, although poor adherence may have contributed to these findings. The second stage involved the assessment of the antiretroviral drug tenofovir, formulated as a vaginal gel, which was found to be modestly effective in a Phase IIb trial (CAPRISA-004) when dosed in a coitally-dependent manner. In another Phase IIb trial, VOICE (MTN-003), tenofovir gel was found to be ineffective when dosed once-daily in a coitally-independent manner. Based on pharmacokinetic data, it was concluded the participants were poorly adherent to this dosing regimen, leading to a lack of efficacy. Tenofovir gel is currently in a Phase III safety and efficacy trial in South Africa (FACTS-001), using the coitally-dependent dosing regimen employed in CAPRISA-004. We are now in the third stage of microbicide research. The antiretroviral drug dapivirine is currently in two Phase III safety and efficacy studies formulated as a vaginal ring. It is hoped that the once-monthly dosing regimen will lead to higher adherence than found in the VOICE study. It is now clear that product adherence could be the greatest challenge to demonstrating

  13. Topical NSAIDs for acute pain in adults

    PubMed Central

    Massey, Thomas; Derry, Sheena; Moore, R Andrew; McQuay, Henry J

    2014-01-01

    Background Use of topical NSAIDs to treat acute musculoskeletal conditions is widely accepted in some parts of the world, but not in others. Their main attraction is their potential to provide pain relief without associated systemic adverse events. Objectives To review the evidence from randomised, double-blind, controlled trials on the efficacy and safety of topically applied NSAIDs in acute pain. Search methods We searched MEDLINE, EMBASE, The Cochrane Library, and our own in-house database to December 2009. We sought unpublished studies by asking personal contacts and searching on-line clinical trial registers and manufacturers web sites. Selection criteria We included randomised, double-blind, active or placebo (inert carrier)-controlled trials in which treatments were administered to adult patients with acute pain resulting from strains, sprains or sports or overuse-type injuries (twisted ankle, for instance). There had to be at least 10 participants in each treatment arm, with application of treatment at least once daily. Data collection and analysis Two review authors independently assessed trial quality and validity, and extracted data. Numbers of participants achieving each outcome were used to calculate relative risk and numbers needed to treat (NNT) or harm (NNH) compared to placebo or other active treatment. Main results Forty-seven studies were included; most compared topical NSAIDs in the form of a gel, spray, or cream with a similar placebo, with 3455 participants in the overall analysis of efficacy. For all topical NSAIDs combined, compared with placebo, the number needed to treat to benefit (NNT) for clinical success, equivalent to 50% pain relief, was 4.5 (3.9 to 5.3) for treatment periods of 6 to 14 days. Topical diclofenac, ibuprofen, ketoprofen, and piroxicam were of similar efficacy, but indomethacin and benzydamine were not significantly better than placebo. Local skin reactions were generally mild and transient, and did not differ from

  14. Apparatus for the production of gel beads containing a biocatalyst

    DOEpatents

    Scott, C.D.; Scott, T.C.; Davison, B.H.

    1998-03-19

    An apparatus is described for the large-scale and continuous production of gel beads containing a biocatalyst. The apparatus is a columnar system based on the chemical cross-linking of hydrocolloidal gels that contain and immobilize a biocatalyst, the biocatalyst being a microorganism or an enzyme. Hydrocolloidal gels, such as alginate, carrageenan, and a mixture of bone gelatin and modified alginate, provide immobilization matrices that can be used to entrap and retain the biocatalyst while allowing effective contact with substrates and release of products. Such immobilized biocatalysts are generally formulated into small spheres or beads that have high concentrations of the biocatalyst within the gel matrix. The columnar system includes a gel dispersion nozzle submerged in a heated non-interacting liquid, typically an organic liquid, that is immiscible with water to allow efficient formation of spherical gel droplets, the non-interacting liquid having a specific gravity that is less than water so that the gel droplets will fall through the liquid by the force of gravity. The heated non-interacting liquid is in direct contact with a chilled upflowing non-interacting liquid that will provide sufficient residence time for the gel droplets as they fall through the liquid so that they will be cooled below the gelling temperature and form solid spheres. The upflowing non-interacting liquid is in direct contact with an upflowing temperature-controlled aqueous solution containing the necessary chemicals for cross-linking or fixing of the gel beads to add the necessary stability. The flow rates of the two liquid streams can be varied to control the proper residence time in each liquid section to accommodate the production of gel beads of differing settling velocities. A valve is provided for continuous removal of the stabilized gel beads from the bottom of the column. 1 fig.

  15. Apparatus for the production of gel beads containing a biocatalyst

    DOEpatents

    Scott, Charles D.; Scott, Timothy C.; Davison, Brian H.

    1998-01-01

    An apparatus for the large-scale and continuous production of gel beads containing a biocatalyst. The apparatus is a columnar system based on the chemical cross-linking of hydrocolloidal gels that contain and immobilize a biocatalyst, the biocatalyst being a microorganism or an enzyme. Hydrocolloidal gels, such as alginate, carrageenan, and a mixture of bone gelatin and modified alginate, provide immobilization matrices that can be used to entrap and retain the biocatalyst while allowing effective contact with substrates and release of products. Such immobilized biocatalysts are generally formulated into small spheres or beads that have high concentrations of the biocatalyst within the gel matrix. The columnar system includes a gel dispersion nozzle submerged in a heated non-interacting liquid, typically an organic liquid, that is immiscible with water to allow efficient formation of spherical gel droplets, the non-interacting liquid having a specific gravity that is less than water so that the gel droplets will fall through the liquid by the force of gravity. The heated non-interacting liquid is in direct contact with a chilled upflowing non-interacting liquid that will provide sufficient residence time for the gel droplets as they fall through the liquid so that they will be cooled below the gelling temperature and form solid spheres. The upflowing non-interacting liquid is in direct contact with an upflowing temperature-controlled aqueous solution containing the necessary chemicals for cross-linking or fixing of the gel beads to add the necessary stability. The flow rates of the two liquid streams can be varied to control the proper residence time in each liquid section to accommodate the production of gel beads of differing settling velocities. A valve is provided for continuous removal of the stabilized gel beads from the bottom of the column.

  16. Formulation and evaluation of Ketoconazole niosomal gel drug delivery system

    PubMed Central

    Shirsand, SB; Para, MS; Nagendrakumar, D; Kanani, KM; Keerthy, D

    2012-01-01

    Purpose: Niosomes play an increasingly important role in drug delivery as they can reduce toxicity and modify pharmacokinetic and bio-availability. Topically applied niosomes can increase the residence time of drugs in the stratum corneum and epidermis, while reducing the systemic absorption of the drug. It can act as drug containing reservoirs and the modification of the vesicular compositions or surface properties can adjust the drug release rate and the affinity for the target site. Ketoconazole is a broad spectrum Imidazole derivative useful in the treatment of superficial and systemic fungal infections. Materials and Methods: In order to improve the low skin penetration and to minimize the side effects associated with topical conventional drug administration, Ketoconazole niosomes were prepared by a thin film hydration method using different ratios of non-ionic surfactants (Span 40, 60 and Tween 60) along with cholesterol (CHO). The formulations were evaluated for size, shape, entrapment efficiency and in vitro drug release. Results: Niosomes appeared spherical in shape and size range was found to be 4.86 ± 1.24-7.38 ± 3.64 μm. The entrapment efficiency was found in the range of 55.14 ± 2.29-78.63 ± 0.91% and in vitro drug release in the range of 46.63 ± 0.95-72.37 ± 0.59% in 24 h. Ketoconazole niosomes formulated with Span 60 and CHO in the ratio of 1:0.2 were found to be promising and were incorporated into 1% Carbopol gel. The formulated gel was evaluated for various physicochemical parameters and antifungal activity. The in vitro drug release study was carried out using phosphate buffer saline pH 7.4 and was found to be 36.18 ± 1.50% in 12 h. Conclusion: Gel formulation containing niosomes loaded with Ketoconazole showed prolonged action than formulations containing Ketoconazole in non-niosomal form and it can be developed successfully to improve the antifungal activity. PMID:23580936

  17. Active DNA gels

    NASA Astrophysics Data System (ADS)

    Saleh, Omar A.; Fygenson, Deborah K.; Bertrand, Olivier J. N.; Park, Chang Young

    2013-02-01

    Research into the mechanics and fluctuations of living cells has revealed the key role played by the cytoskeleton, a gel of stiff filaments driven out of equilibrium by force-generating motor proteins. Inspired by the extraordinary mechanical functions that the cytoskeleton imparts to the cell, we sought to create an artificial gel with similar characteristics. We identified DNA, and DNA-based motor proteins, as functional counterparts to the constituents of the cytoskeleton. We used DNA selfassembly to create a gel, and characterized its fluctuations and mechanics both before and after activation by the motor. We found that certain aspects of the DNA gel quantitatively match those of cytoskeletal networks, indicating the universal features of motor-driven, non-equilibrium networks.

  18. Thermosetting gels with modulated gelation temperature for ophthalmic use: the rheological and gamma scintigraphic studies.

    PubMed

    Wei, Gang; Xu, Hui; Ding, Ping Tian; Li, San Ming; Zheng, Jun Min

    2002-09-18

    For ophthalmic drug delivery, Pluronic F127 solutions have a phase transition temperature too low for them to be instilled into the eye at room temperature. Refrigerator storage is usually required to make administration easier, whereas the potential irritation of cold to the sensitive ocular tissues may result in poor topical bioavailability. The purpose of this study is to develop a thermosetting gel with a suitable phase transition temperature by combining Pluronic analogs and to examine the influence of incorporating mucoadhesive polysaccharide, sodium hyaluronate (HA-Na), on the ocular retention of the gel. Dynamic rheological method and single photon emission computing tomography (SPECT) technique were used to ex/in vivo evaluate the thermosetting gels, respectively. An optimized formulation containing 21% F127 and 10% F68 increased the phase transition temperature by 9 degrees C as evaluated by elasticity modulus compared to that of individual 21% F127 solution. Rheological behaviors of the Pluronic solutions showed that the combined Pluronic formulation was free flowing liquid below 25 degrees C and converted to a firm gel under the physiological condition. Furthermore, this formulation possessed the highest viscosity both before and after tear dilution at 35 degrees C. Gamma scintigraphic data demonstrated that the clearance of the thermosetting gel labeled with 99mTc-DTPA was significantly delayed with respect to the phosphate buffered solution, and at least a threefold increase of the corneal residence time was achieved. However, no further improvement in the ocular retention was observed when adding HA-Na into the thermosetting gel due to the substantially decreased gel strength. Copyright 2002 Elsevier Science B.V.

  19. Capsaicin-loaded nanolipoidal carriers for topical application: design, characterization, and in vitro/in vivo evaluation.

    PubMed

    Wang, Xia-Rong; Gao, Si-Qian; Niu, Xiao-Qian; Li, Long-Jian; Ying, Xiao-Ying; Hu, Zhong-Jie; Gao, Jian-Qing

    2017-01-01

    Capsaicin has been used in clinical applications for the treatment of pain disorders and inflammatory diseases. Given the strong pungency and high oil/water partition coefficient of capsaicin, capsaicin-loaded nanolipoidal carriers (NLCs) were designed to increase permeation and achieve the analgesic, anti-inflammatory effect with lower skin irritation. Capsaicin-loaded NLCs were prepared and later optimized by the Box-Behnken design. The physicochemical characterizations, morphology, and encapsulation of the capsaicin-loaded NLCs were subsequently confirmed. Capsaicin-loaded NLCs and capsaicin-loaded NLCs gel exhibited sustained release and no cytotoxicity properties. Also, they could significantly enhance the penetration amount, permeation flux, and skin retention amounts of capsaicin due to the application of NLCs. To study the topical permeation mechanism of capsaicin, 3,3'-dioctadecyloxacarbocyanine perchlorate (Dio) was used as a fluorescent dye. Dio-loaded NLCs and Dio-loaded NLCs gel could effectively deliver Dio up to a skin depth of 260 and 210 μm, respectively, primarily through the appendage route on the basis of version skin sections compared with Dio solution, which only delivered Dio up to 150 μm. In vivo therapeutic experiments demonstrated that capsaicin-loaded NLCs and capsaicin-loaded NLCs gel could improve the pain threshold in a dose-dependent manner and inhibit inflammation, primarily by reducing the prostaglandin E2 levels in the tissue compared with capsaicin cream and capsaicin solution. Meanwhile, skin irritation was reduced, indicating that application of NLCs could decrease the irritation caused by capsaicin. Overall, NLCs may be a potential carrier for topical delivery of capsaicin for useful pain and inflammation therapy.

  20. Metal-silica sol-gel materials

    NASA Technical Reports Server (NTRS)

    Stiegman, Albert E. (Inventor)

    2002-01-01

    The present invention relates to a single phase metal-silica sol-gel glass formed by the co-condensation of a transition metal with silicon atoms where the metal atoms are uniformly distributed within the sol-gel glass as individual metal centers. Any transition metal may be used in the sol-gel glasses. The present invention also relates to sensor materials where the sensor material is formed using the single phase metal-silica sol-gel glasses. The sensor materials may be in the form of a thin film or may be attached to an optical fiber. The present invention also relates to a method of sensing chemicals using the chemical sensors by monitoring the chromatic change of the metal-silica sol-gel glass when the chemical binds to the sensor. The present invention also relates to oxidation catalysts where a metal-silica sol-gel glass catalyzes the reaction. The present invention also relates to a method of performing oxidation reactions using the metal-silica sol-gel glasses. The present invention also relates to organopolymer metal-silica sol-gel composites where the pores of the metal-silica sol-gel glasses are filled with an organic polymer polymerized by the sol-gel glass.

  1. Availability of a containerless polymer gel detector and a gelatin container

    NASA Astrophysics Data System (ADS)

    Tominaga, Takahiro; Yoshioka, Munenori; Hayashi, Shin-ichiro; Usui, Shuji; Tada, Mitsutoshi

    2015-01-01

    We considered an availability of the polymer gel detector without container but with a plastic wrap under assumption of the low oxygen transmissivity of a sheet of plastic wrap. And a gelatin container was also examined for a gel detector. These samples can be made easily and this containerless polymer gel detector well works without any artifacts by means of wrapping with a thin plastic sheet. Nevertheless, there is still room for improvement on preventing oxygen contamination. Combination with a gelatin container and a polymer gel detector and/or Gafchromic films has a various potential for extension of 3D dosimetry.

  2. Next Science Wound Gel Technology, a Novel Agent That Inhibits Biofilm Development by Gram-Positive and Gram-Negative Wound Pathogens

    PubMed Central

    Miller, Kyle G.; Tran, Phat L.; Haley, Cecily L.; Kruzek, Cassandra; Colmer-Hamood, Jane A.; Myntti, Matt

    2014-01-01

    Loss of the skin barrier facilitates the colonization of underlying tissues with various bacteria, where they form biofilms that protect them from antibiotics and host responses. Such wounds then become chronically infected. Topical antimicrobials are a major component of chronic wound therapy, yet currently available topical antimicrobials vary in their effectiveness on biofilm-forming pathogens. In this study, we evaluated the efficacy of Next Science wound gel technology (NxtSc), a novel topical agent designed to kill planktonic bacteria, penetrate biofilms, and kill the bacteria within. In vitro quantitative analysis, using strains isolated from wounds, showed that NxtSc inhibited biofilm development by Staphylococcus aureus, Staphylococcus epidermidis, Pseudomonas aeruginosa, Acinetobacter baumannii, and Klebsiella pneumoniae by inhibiting bacterial growth. The gel formulation NxtSc-G5, when applied to biofilms preformed by these pathogens, reduced the numbers of bacteria present by 7 to 8 log10 CFU/disc or CFU/g. In vivo, NxtSc-G5 prevented biofilm formation for 72 h when applied at the time of wounding and infection and eliminated biofilm infection when applied 24 h after wounding and infection. Storage of NxtSc-G5 at room temperature for 9 months did not diminish its efficacy. These results establish that NxtSc is efficacious in vitro and in vivo in preventing infection and biofilm development by different wound pathogens when applied immediately and in eliminating biofilm infection already established by these pathogens. This novel antimicrobial agent, which is nontoxic and has a usefully long shelf life, shows promise as an effective agent for the prevention and treatment of biofilm-related infections. PMID:24637684

  3. Retrospective study of radiotherapy-induced skin reactions in breast cancer patients: reduced incidence of moist desquamation with a hydroactive colloid gel versus dexpanthenol.

    PubMed

    Censabella, Sandrine; Claes, Stefan; Orlandini, Marc; Braekers, Roel; Thijs, Herbert; Bulens, Paul

    2014-10-01

    Dermatitis is a very frequent and distressing side effect of radiation therapy that may necessitate a treatment interruption when evolving towards more severe forms such as moist desquamation (MD). The aim of this study was to compare the efficacy of two topical agents, a dexpanthenol cream vs a hydroactive colloid gel combining absorbing and moisturising properties, in preventing MD in breast cancer patients. This retrospective study compared two successive groups of breast cancer patients undergoing radiotherapy after breast-sparing surgery between 2008 and 2012. A group of 267 patients applied a 5% dexpanthenol cream on the irradiated zone throughout the course of their radiotherapy. Another group of 216 patients applied first the dexpanthenol cream then replaced it by the hydroactive colloid gel after 11-14 days of radiotherapy. Radiation treatment (total dose, technique, and equipment) was the same for the two groups. The clinical outcomes were the occurrence and time to onset of moist desquamation. The overall incidence of MD was significantly lower in patients who applied the hydroactive colloid gel (16%) than in those who applied the dexpanthenol cream (32%, odds-ratio = 0.35). Also, MD occurred significantly later with the hydroactive colloid gel than with the dexpanthenol cream (hazard ratio = 0.39). Compared with the dexpanthenol cream, the hydroactive colloid gel significantly reduced the risk of developing MD in patients undergoing radiotherapy for breast cancer. These promising results warrant further research on the efficacy of hydroactive colloid gels in managing radiation dermatitis. Copyright © 2014 Elsevier Ltd. All rights reserved.

  4. Fouling mechanisms of gel layer in a submerged membrane bioreactor.

    PubMed

    Hong, Huachang; Zhang, Meijia; He, Yiming; Chen, Jianrong; Lin, Hongjun

    2014-08-01

    The fouling mechanisms underlying gel layer formation and its filtration resistance in a submerged membrane bioreactor (MBR) were investigated. It was found that gel layer rather than cake layer was more easily formed when soluble microbial products content in sludge suspension was relatively high. Thermodynamic analyses showed that gel layer formation process should overcome a higher energy barrier as compared with cake layer formation process. However, when separation distance <2.3 nm, attractive interaction energy of gelling foulant-membrane combination was remarkably higher than that of sludge floc-membrane combination. The combined effects were responsible for gel layer formation. Filtration tests showed that specific filtration resistance (SFR) of gel layer was almost 100 times higher than that of cake layer. The unusually high SFR of gel layer could be ascribed to the gelling propensity and osmotic pressure mechanism. These findings shed significant light on fouling mechanisms of gel layer in MBRs. Copyright © 2014 Elsevier Ltd. All rights reserved.

  5. Crystallization from Gels

    NASA Astrophysics Data System (ADS)

    Narayana Kalkura, S.; Natarajan, Subramanian

    Among the various crystallization techniques, crystallization in gels has found wide applications in the fields of biomineralization and macromolecular crystallization in addition to crystallizing materials having nonlinear optical, ferroelectric, ferromagnetic, and other properties. Furthermore, by using this method it is possible to grow single crystals with very high perfection that are difficult to grow by other techniques. The gel method of crystallization provides an ideal technique to study crystal deposition diseases, which could lead to better understanding of their etiology. This chapter focuses on crystallization in gels of compounds that are responsible for crystal deposition diseases. The introduction is followed by a description of the various gels used, the mechanism of gelling, and the fascinating phenomenon of Liesegang ring formation, along with various gel growth techniques. The importance and scope of study on crystal deposition diseases and the need for crystal growth experiments using gel media are stressed. The various crystal deposition diseases, viz. (1) urolithiasis, (2) gout or arthritis, (3) cholelithiasis and atherosclerosis, and (4) pancreatitis and details regarding the constituents of the crystal deposits responsible for the pathological mineralization are discussed. Brief accounts of the theories of the formation of urinary stones and gallstones and the role of trace elements in urinary stone formation are also given. The crystallization in gels of (1) the urinary stone constituents, viz. calcium oxalate, calcium phosphates, uric acid, cystine, etc., (2) the constituents of the gallstones, viz. cholesterol, calcium carbonate, etc., (3) the major constituent of the pancreatic calculi, viz., calcium carbonate, and (4) cholic acid, a steroidal hormone are presented. The effect of various organic and inorganic ions, trace elements, and extracts from cereals, herbs, and fruits on the crystallization of major urinary stone and gallstone

  6. Spongy Gels by a Top-Down Approach from Polymer Fibrous Sponges.

    PubMed

    Jiang, Shaohua; Duan, Gaigai; Kuhn, Ute; Mörl, Michaela; Altstädt, Volker; Yarin, Alexander L; Greiner, Andreas

    2017-03-13

    Ultralight cellular sponges offer a unique set of properties. We show here that solvent uptake by these sponges results in new gel-like materials, which we term spongy gels. The appearance of the spongy gels is very similar to classic organogels. Usually, organogels are formed by a bottom-up process. In contrast, the spongy gels are formed by a top-down approach that offers numerous advantages for the design of their properties, reproducibility, and stability. The sponges themselves represent the scaffold of a gel that could be filled with a solvent, and thereby form a mechanically stable gel-like material. The spongy gels are independent of a time-consuming or otherwise demanding in situ scaffold formation. As solvent evaporation from gels is a concern for various applications, we also studied solvent evaporation of wetting and non-wetting liquids dispersed in the sponge. © 2017 The Authors. Published by Wiley-VCH Verlag GmbH & Co. KGaA.

  7. Optimal processing for gel electrophoresis images: Applying Monte Carlo Tree Search in GelApp.

    PubMed

    Nguyen, Phi-Vu; Ghezal, Ali; Hsueh, Ya-Chih; Boudier, Thomas; Gan, Samuel Ken-En; Lee, Hwee Kuan

    2016-08-01

    In biomedical research, gel band size estimation in electrophoresis analysis is a routine process. To facilitate and automate this process, numerous software have been released, notably the GelApp mobile app. However, the band detection accuracy is limited due to a band detection algorithm that cannot adapt to the variations in input images. To address this, we used the Monte Carlo Tree Search with Upper Confidence Bound (MCTS-UCB) method to efficiently search for optimal image processing pipelines for the band detection task, thereby improving the segmentation algorithm. Incorporating this into GelApp, we report a significant enhancement of gel band detection accuracy by 55.9 ± 2.0% for protein polyacrylamide gels, and 35.9 ± 2.5% for DNA SYBR green agarose gels. This implementation is a proof-of-concept in demonstrating MCTS-UCB as a strategy to optimize general image segmentation. The improved version of GelApp-GelApp 2.0-is freely available on both Google Play Store (for Android platform), and Apple App Store (for iOS platform). © 2016 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

  8. Effects of topical budesonide on epithelial restitution in vivo in guinea pig trachea.

    PubMed Central

    Erjefält, J. S.; Erjefält, I.; Sundler, F.; Persson, C. G.

    1995-01-01

    BACKGROUND--Continuous epithelial shedding and restitution processes may characterise the airways in diseases such as asthma. Epithelial restitution involves several humoral and cellular mechanisms that may potentially be affected by inhaled anti-asthma drugs. The present study examines the effect of a topical steroid on epithelial restitution in vivo in the guinea pig. METHODS--The airway epithelium was mechanically removed from well defined areas of guinea pig trachea without surgery and without damage to the basement membrane or bleeding. An anti-inflammatory dose of budesonide (1 mg) was administered repeatedly to the tracheal surface by local superfusion 24 hours before, at (0 hours), and 24 hours after the denudation. Migration of epithelial cells, formation of a plasma exudation-derived gel, and appearance of luminal leucocytes were recorded by scanning electron microscopy. Cell proliferation was visualised by bromodeoxyuridine immunohistochemistry and tissue neutrophils and eosinophils by enzyme histochemistry. RESULTS--Immediately after creation of the denuded zone ciliated and secretory cells on its border dedifferentiated, flattened out, and migrated speedily (mean (SE) 2.3 (0.3) micron/min) over the basement membrane. After 48 hours the entire denuded zone (800 microns wide) was covered by a tightly sealed epithelium; at this time increased proliferation was observed in new and old epithelium and subepithelial cells. Budesonide had no detectable effect on epithelial dedifferentiation, migration, sealing, or proliferation. Immediately after denudation and continuously during the migration phase plasma was extravasated creating a fibrinous gel rich in leucocytes, particularly neutrophils, over the denuded area. Budesonide had no effect on either the gel or the leucocyte density. CONCLUSIONS--These observations suggest that topical glucocorticoids may not interfere with a fast and efficient restitution of the epithelium in the airways. Images PMID:7570417

  9. A pneumatic device for rapid loading of DNA sequencing gels.

    PubMed

    Panussis, D A; Cook, M W; Rifkin, L L; Snider, J E; Strong, J T; McGrane, R M; Wilson, R K; Mardis, E R

    1998-05-01

    This work describes the design and construction of a device that facilitates the loading of DNA samples onto polyacrylamide gels for detection in the Perkin Elmer/Applied Biosystems (PE/ABI) 373 and 377 DNA sequencing instruments. The device is mounted onto the existing gel cassettes and makes the process of loading high-density gels less cumbersome while the associated time and errors are reduced. The principle of operation includes the simultaneous transfer of the entire batch of samples, in which a spring-loaded air cylinder generates positive pressure and flexible silica capillaries transfer the samples. A retractable capillary array carrier allows the delivery ends of the capillaries to be held up clear of the gel during loader attachment on the gel plates, while enabling their insertion in the gel wells once the device is securely mounted. Gel-loading devices capable of simultaneously transferring 72 samples onto the PE/ABI 373 and 377 are currently being used in our production sequencing groups while a 96-sample transfer prototype undergoes testing.

  10. Organization versus frustration: low temperature transitions in a gelatine-based gel

    NASA Astrophysics Data System (ADS)

    Philipp, M.; Müller, U.; Sanctuary, R.; Baller, J.; Krüger, J. K.

    2008-09-01

    A commercial physical gel composed of gelatine, water and glycerol shows a sol-gel transition which has been resolved by optical rotation measurements by step-wise heating the gel. This transition is not observable in the longitudinal acoustic mode measured at hypersonic frequencies with Brillouin spectroscopy. Depending on the thermal treatment of the investigated material during the sol-gel transition and within the gel state, Brillouin spectroscopy reflects tremendously different hypersonic dynamics. These distinct dynamics are responsible for the formation of different glassy states at low temperatures including that of a glass-ceramic. The large variety of super-cooled and glassy states is attributed to distinct distributions of the gel's constituents within the samples. Surprisingly, the same gel state can be produced either by annealing the gel over months or by the non-equilibrium effect of thermo-diffusion (Soret effect) in the course of some minutes.

  11. Hermeneutics and Victimage: A Critical Approach to News of the Shooting of KAL Flight 007.

    ERIC Educational Resources Information Center

    Lule, Jack

    The shooting down of KAL Flight 007, a South Korean airliner, by a Soviet jet fighter, and the resulting deaths of the 269 people on board, has brought into focus the Reagan's administration's equivocal relationship with the Soviet Union, provided insights into the channels of power in the Soviet military hierarchy, and led other nations to…

  12. Pharmacokinetic modeling of a gel-delivered dapivirine microbicide in humans.

    PubMed

    Halwes, Michael E; Steinbach-Rankins, Jill M; Frieboes, Hermann B

    2016-10-10

    Although a number of drugs have been developed for the treatment and prevention of human immunodeficiency virus (HIV) infection, it has proven difficult to optimize the drug and dosage parameters. The vaginal tissue, comprised of epithelial, stromal and blood compartments presents a complex system which challenges evaluation of drug kinetics solely through empirical effort. To provide insight into the underlying processes, mathematical modeling and computational simulation have been applied to the study of retroviral microbicide pharmacokinetics. Building upon previous pioneering work that modeled the delivery of Tenofovir (TFV) via topical delivery to the vaginal environment, here we computationally evaluate the performance of the retroviral inhibitor dapivirine released from a microbicide gel. We adapt the TFV model to simulate the multicompartmental diffusion and uptake of dapivirine into the blood plasma and vaginal compartments. The results show that dapivirine is expected to accumulate at the interface between the gel and epithelium compartments due to its hydrophobic characteristics. Hydrophobicity also results in decreased diffusivity, which may impact distribution by up to 2 orders of magnitude compared to TFV. Maximum concentrations of dapivirine in the epithelium, stroma, and blood were 9.9e7, 2.45e6, and 119pg/mL, respectively. This suggests that greater initial doses or longer time frames are required to obtain higher drug concentrations in the epithelium. These observations may have important ramifications if a specific time frame is required for efficacy, or if a minimum/maximum concentration is needed in the mucus, epithelium, or stroma based on combined efficacy and safety data. Copyright © 2016 Elsevier B.V. All rights reserved.

  13. Chemico-therapeutic approach to prevention of dental caries. [using stannous fluoride gel

    NASA Technical Reports Server (NTRS)

    Shannon, I. L.

    1975-01-01

    The program of chemical preventive dentistry is based primarily upon the development of a procedure for stabilizing stannous fluoride in solution by forcing it into glycerin. New topical fluoride treatment concentrates, fluoride containing gels and prophylaxis pastes, as well as a completely stable stannous fluoride dentifrice are made possible by the development of a rather complicated heat application method to force stannous fluoride into solution in glycerin. That the stannous fluoride is clinically effective in such a preparation is demonstrated briefly on orthodontic patients.

  14. 3-Acetyl-11-keto-beta-boswellic acid loaded-polymeric nanomicelles for topical anti-inflammatory and anti-arthritic activity.

    PubMed

    Goel, Amit; Ahmad, Farhan Jalees; Singh, Raman Mohan; Singh, Gyanendra Nath

    2010-02-01

    The aim of this study was to develop 3-acetyl-11-keto-beta-boswellic acid (AKBA)-loaded polymeric nanomicelles for topical anti-inflammatory and anti-arthritic activity. Polymeric nanomicelles of AKBA were developed by a radical polymerization method using N-isopropylacrylamide, vinylpyrrolidone and acrylic acid. The polymeric nanomicelles obtained were characterized by Fourier transform infrared (FTIR), transmission electron microscopy (TEM) and dynamic light scattering (DLS). In-vitro and in-vivo evaluations of AKBA polymeric nanomicelles gel were carried out for enhanced skin permeability and anti-inflammatory and anti-arthritic activity. TEM and DLS results demonstrated that polymeric nanomicelles were spherical with a mean diameter approximately 45 nm. FTIR data indicated a weak interaction between polymer and AKBA in the encapsulated system. The release of drug in aqueous buffer (pH 7.4) from the polymeric nanomicelles was 23 and 55% after 2 and 8 h, respectively, indicating sustained release. In-vitro skin permeation studies through excised abdominal skin indicated a threefold increase in skin permeability compared with AKBA gel containing the same amount of AKBA as the AKBA polymeric nanomicelles gel. The AKBA polymeric nanomicelle gel showed significantly enhanced anti-inflammatory and anti-arthritic activity compared with the AKBA gel. This study suggested that AKBA polymeric nanomicelle gel significantly enhanced skin permeability, and anti-inflammatory and anti-arthritic activity.

  15. [The effect of locally applied Grisaldone or choline salicylate gel on bone healing after tooth extraction in animal experiments].

    PubMed

    Cendelin, E; Fröhlich, M

    1977-01-01

    Comparative histological and experimental animal studies of the effects upon bone wound healing of topically applied choline salicylate gel and Grisaldon showed that Grisaldon tends to hinder the course of reparation of bone, whereas choline salicylate gel has no appreciable influence upon the time course of wound healing. This essential difference is considered to be due predominantly to the exactly opposite behavior shown by the two pharmaceutical preparations in regard to their solubility in water. The difficultly watersoluble Grisaldon tends to exert a longer-drawn-out irritant effect upon the tissue and can be detected in alveoli even after twenty-eight days from administration thereof. By contrast, choline salicylate gel, which is known to be readily soluble in water, will be eliminated already after two days from administration thereof.

  16. Topical colloidal silver as an anti-biofilm agent in a Staphylococcus aureus chronic rhinosinusitis sheep model.

    PubMed

    Rajiv, Sukanya; Drilling, Amanda; Bassiouni, Ahmed; James, Craig; Vreugde, Sarah; Wormald, Peter-John

    2015-04-01

    Treatment of recalcitrant chronic rhinosinusitis (CRS) is a challenge with increasing antibiotic resistance, leading to re-emergence of topical therapies. The aim of this study was to assess safety and efficacy of topical colloidal silver solution for the treatment of Staphylococcus aureus biofilms in a sheep model. In the safety study, normal saline (control) and 30-ppm colloidal silver solution (test) was used to flush the frontal sinuses for 14 days in 8 sheep (4 sheep each). In the efficacy study, following frontal sinus infection with Staphylococcus aureus, sheep were treated with either control saline or topical silver solution of varying concentrations (30 ppm/20 ppm/10 ppm/5 ppm) for 5 days, with 4 sheep in each group. Blood silver level, full blood counts, and biochemical parameters were analyzed in both safety and efficacy studies. Sinus tissue was harvested for histological examination and ciliary structure analysis in safety and for biofilm biomass quantification by fluorescence in situ hybridization (FISH) technique and COMSTAT 2 software in the efficacy study. Results were analyzed using appropriate statistical tests. Sheep treated with silver showed a significant decrease in biofilm biomass (0.004, 0.004, 0.004, and 0.007, in the 4 silver-treated groups, respectively) compared to saline control (0.175), p < 0.001. Although average blood silver levels were higher in the treated groups compared to controls (p < 0.05), blood counts and biochemical parameters were normal. Histology and ciliary structure analysis did not show any difference between control and treatment groups. Topical colloidal silver solution has effective antibiofilm activity in Staphylococcus aureus CRS in a sheep model and appears safe. © 2015 ARS-AAOA, LLC.

  17. Validation of reference genes for RT-qPCR analysis in Burkholderia pyrrocinia JK-SH007.

    PubMed

    Wu, Bin-Yan; Ye, Jian-Ren; Huang, Lin; He, Ling-Min; Li, De-Wei

    2017-01-01

    Burkholderia pyrrocinia strain JK-SH007 isolated from poplar stems plays a highly significant role in the growth promotion and the biocontrol of poplar canker during colonization in poplar. In this research, the ideal reference gene was filtered and determined for the transcript normalization. Additionally, the expression of pyrG under all four conditions was relatively stable in B. pyrrocinia JK-SH007. Copyright © 2016. Published by Elsevier B.V.

  18. Development of paclitaxel-TyroSpheres for topical skin treatment

    PubMed Central

    Kilfoyle, Brian E.; Sheihet, Larisa; Zhang, Zheng; Laohoo, Marissa; Kohn, Joachim; Michniak-Kohn, Bozena B.

    2012-01-01

    A potential topical psoriasis therapy has been developed consisting of tyrosine-derived nanospheres (TyroSpheres) with encapsulated anti-proliferative paclitaxel. TyroSpheres provide enhancement of paclitaxel solubility (almost 4,000 times greater than PBS) by effective encapsulation and enable sustained, dose-controlled release over 72 hours under conditions mimicking skin permeation. TyroSpheres offer potential in the treatment of psoriasis, a disease resulting from over-proliferation of keratinocytes in the basal layer of the epidermis, by (a) enabling delivery of paclitaxel into the epidermis at concentrations >100 ng/cm2 of skin surface area and (b) enhancing the cytotoxicity of loaded paclitaxel to human keratinocytes (IC50 of paclitaxel-TyroSpheres was approximately 45% lower than that of free paclitaxel). TyroSpheres were incorporated into a gel-like viscous formulation to improve their flow characteristics with no impact on homogeneity, release or skin distribution of the payload. The findings reported here confirm that the TyroSpheres provide a platform for paclitaxel topical administration allowing skin drug localization and minimal systemic escape. PMID:22732474

  19. Direct Force Measurements on Neurofilaments: Gel Expanded to Gel Condensed Transition

    NASA Astrophysics Data System (ADS)

    Beck, R.; Deek, J.; Jones, J. B.; Safinya, C. R.

    2010-03-01

    Neurofilaments (NFs)--the major cytoskeletal constituent of axons in vertebrates, consist of three subunit proteins assembled to form filaments with protruding unstructured C-terminus sidearms. Liquid crystal gel networks of sidearm-mediated NF assemblies play a key role in the mechanical while disruptions of this network, due to over-accumulation or incorrect sidearm interactions, are a hallmark of motor neuron diseases. Using synchrotron SAXS [1,2] and microscopy techniques [1,3] we report a direct force measurement of reconstituted NF-gels under osmotic pressure (P), which revealed the role of subunit sidearms on structure and interaction of NFs. With increasing P, near physiological condition, the gels undergo an abrupt nonreversible gel expanded to gel condensed transition that indicates sidearm-mediated attractions between NFs. This attraction is consistent with an electrostatic model of interpenetrating chains.[4pt] [1] J.B. Jones, C.R. Safinya, Biophys. J. 95, 823 (2008);[0pt] [2] R. Beck et al., Nature Mat. (2009) in press;[0pt] [3] H. Hess et al. Langmuir 24, 8397 (2008)

  20. Topical delivery of aceclofenac from lecithin organogels: preformulation study.

    PubMed

    Shaikh, I M; Jadhav, K R; Gide, P S; Kadam, V J; Pisal, S S

    2006-10-01

    The purpose of this research is to evaluate the suitability of lecithin organogels containing aceclofenac for topical application. The present article focuses on the preformulation part of the whole research work. Thin layer chromatography was carried out to determine lecithin's purity. The excipients for formulating lecithin organogel were screened. Lecithin organogels are thermo reversible in nature and hence gelation temperature study was carried out to determine the temperature where Sol-Gel and Gel-Sol transformation takes place. Partition coefficient of the drug was estimated. Drug solubility in plain oil and organogel containing reverse micelles was estimated. Effect of water added on the properties of lecithin organogels such as X-ray diffraction pattern, conductivity and viscosity were determined. Microscopy of the gel sample has been carried out at different magnifications. The pseudo ternary phase diagram has been constructed to determine the organogel existence region. The permeation study of aceclofenac from different concentrations of lecithin organogels [200 mM, 300 mM and 400 mM] has been determined using cellulose acetate membrane (0.45 micro) and excised rat skin. Lecithin organogel in ethyl oleate has desired stability and consistency. A single spot on the TLC plate confirms the purity of soy lecithin to be used in organogel formation. Aceclofenac solubility was found to be more in lecithin/oil reverse micellar system as compared to its solubility in oil. The X-ray diffraction pattern confirms the incorporation of water in micellar gel network. The physical properties of organogels are affected by water incorporated and concentration of gelator. The permeation of aceclofenac through artificial membrane and excised rat skin demonstrated the same trend and were in the following order 200 mM>300 mM>400 mM. The results showed that organogel exhibits useful pharmaceutical properties.

  1. [Polymer Gel Dosimeter].

    PubMed

    Hayashi, Shin-Ichiro

    2017-01-01

    With rapid advances being made in radiotherapy treatment, three-dimensional (3D) dose measurement techniques of great precision are required more than ever before. It is expected that 3D polymer gel dosimeters will satisfy clinical needs for an effective detector that can measure the complex 3D dose distributions. Polymer gel dosimeters are devices that utilize the radiation-induced polymerization reactions of vinyl monomers in a gel to store information about radiation dose. The 3D absorbed dose distribution can be deduced from the resulting polymer distribution using several imaging modalities, such as MRI, X-ray and optical CTs. In this article, the fundamental characteristics of polymer gel dosimeter are reviewed and some challenging keys are also suggested for the widely spread in clinical use.

  2. Ingenol mebutate gel treatment for actinic cheilitis: report of four cases.

    PubMed

    Barrado Solís, Nerea; Molés Poveda, Paula; Lloret Ruiz, César; Pont Sanjuan, Virginia; Velasco Pastor, Manel; Quecedo Estébanez, Esther; Miquel Miquel, Javier

    2015-01-01

    Actinic cheilitis (AC) are premalignant lesions that have an increased risk of malignant transformation. Their treatment, therefore, is essential to prevent carcinogenesis. However, optimal therapy is not well established and different modalities yield variable results. Ingenol mebutate gel has recently been approved by the US Food and Drug Administration for topical treatment of actinic keratosis, with high clearance rates. On the basis of these findings, we report our experience with this drug for the treatment of AC. © 2014 Wiley Periodicals, Inc.

  3. Highly efficient treatment of aerobic vaginitis with simple acidic buffered gels: The importance of pH and buffers on the microenvironment of vaginas.

    PubMed

    Sun, Xiaodong; Qiu, Haiying; Jin, Yiguang

    2017-06-15

    Aerobic vaginitis (AV) leads to uterus deep infection or preterm birth. Antibacterial agents are not optimal therapeutics of AV. Here, we report a series of temperature-sensitive in situ forming acidic buffered gels for topical treatment of AV, involving lactate, acetate, and citrate gels at pH 3.5, 5.0, and 6.5. AV rat models were prepared following vaginal infection with Staphylococcus aureus and Escherichia coli. In vitro/in vivo studies of the buffered gels were performed compared with ofloxacin gels and blank gels. All the buffered gels showed the lower in vitro antibacterial activities than ofloxacin gels but the better in vivo anti-S. aureus effects and similar anti-E. coli effects. The buffered gels improved Lactobacillus growth in the vaginas. Both the healthy rat vaginal pH and the pH of rat vaginas treated with the buffered gels were about 6.5 though the AV rat models or ones treated with ofloxacin gels still remained at the high pH more than 7.0. After treatments with the buffered gels, the vaginal smears changed to a clean state nearly without aerobic bacteria, the vaginal tissues were refreshed, and the immunoreactions were downregulated. The acidic buffered gels bring rapid decrease of local vaginal pH, high antibacterial activities, improvement of probiotics, and alleviation of inflammation. They are simple, highly efficient, and safe anti-AV formulations. Copyright © 2017 Elsevier B.V. All rights reserved.

  4. Anti-thrombotic efficacy of S007-867: Pre-clinical evaluation in experimental models of thrombosis in vivo and in vitro.

    PubMed

    Misra, Ankita; Prakash, Prem; Aggarwal, Hobby; Dhankani, Priyanka; Kumar, Sachin; Pandey, Chandra Prakash; Pugh, Nicholas; Bihan, Dominique; Barthwal, Manoj Kumar; Farndale, Richard W; Dikshit, Dinesh Kumar; Dikshit, Madhu

    2018-02-01

    Pharmacological inhibition of platelet collagen interaction is a promising therapeutic strategy to treat intra-vascular thrombosis. S007-867 is a novel synthetic inhibitor of collagen-induced platelet aggregation. It has shown better antithrombotic protection than aspirin and clopidogrel with minimal bleeding tendency in mice. The present study is aimed to systematically investigate the antithrombotic efficacy of S007-867 in comparison to aspirin and clopidogrel in vivo and to delineate its mechanism of action in vitro. Aspirin, clopidogrel, and S007-867 significantly reduced thrombus weight in arterio-venous (AV) shunt model in rats. In mice, following ferric chloride induced thrombosis in either carotid or mesenteric artery; S007-867 significantly prolonged the vessel occlusion time (1.2-fold) and maintained a sustained blood flow velocity for >30 min. Comparatively, clopidogrel showed significant prolongation in TTO (1.3-fold) while aspirin remained ineffective. Both S007-867 and aspirin did not alter bleeding time in either kidney or spleen injury models, and thus maintained hemostasis, while clopidogrel showed significant increase in spleen bleeding time (1.7-fold). The coagulation parameters namely thrombin time, prothrombin time or activated partial thromboplastin time remained unaffected even at high concentration of S007-867 (300 µM), thus implying its antithrombotic effect to be primarily platelet mediated. S007-867 significantly inhibited collagen-mediated platelet adhesion and aggregation in mice ex-vivo. Moreover, when blood was perfused over a highly thrombogenic combination of collagen mimicking peptides like CRP-GFOGER-VWF-III, S007-867 significantly reduced total thrombus volume or ZV 50 (53.4 ± 5.7%). Mechanistically, S007-867 (10-300 μM) inhibited collagen-induced ATP release, thromboxane A 2 (TxA 2 ) generation, intra-platelet [Ca +2 ] flux and global tyrosine phosphorylation including PLCγ2. Collectively the present study

  5. Efficacy and safety of diclofenac diethylamine 2.32% gel in acute ankle sprain.

    PubMed

    Predel, Hans-Georg; Hamelsky, Sandra; Gold, Morris; Giannetti, Bruno

    2012-09-01

    Topical diclofenac diethylamine (DDEA) 2.32% gel achieves lasting efficacy in localized pain with two applications per day, while maintaining the favorable safety profile of topical diclofenac and potentially improving convenience and patient compliance. This randomized double-blind controlled study enrolled patients with acute ankle sprain treated with DDEA 2.32% gel two times per day (bid) (n = 80) or three times per day (tid) (n = 80) or placebo (n = 82). Efficacy (including pain and swelling) and local tolerability were evaluated during 8 ± 1 d. By day 5, the reduction in pain on movement (POM) (primary efficacy variable) with DDEA bid and tid (49.1 and 49.7 mm, respectively; 100-mm visual analog scale) was almost double that with placebo (25.4 mm) (P < 0.0001). In patients with severe baseline POM (≥ 80 mm), mean change in POM from baseline to day 5 with DDEA bid or tid was 30-40 mm greater than that with placebo, which was double the difference (15-20 mm) in patients with mild-moderate baseline POM (<80 mm). More than 70% of all DDEA patients experienced ≥ 50% reduction in POM between days 1 and 5 versus 21% of placebo patients (P < 0.0001). By study end (day 8), ankle swelling in patients treated with DDEA (0.3 cm) was one-third that in those treated with placebo (0.9 cm) (P < 0.0001), which had still not achieved the level of ankle joint function seen with DDEA on day 5 (P < 0.0001). At day 5, treatment satisfaction was "good" to "excellent" in almost 90% of DDEA patients but only "good" or "very good" in 23% of placebo patients (P < 0.0001). DDEA 2.32% gel was well tolerated. DDEA 2.32% gel twice daily (applied in the morning and evening) was well tolerated and provided lasting relief from pain, improved function, and reduced symptomatic healing time in uncomplicated ankle sprain.

  6. Osteochondral Biopsy Analysis Demonstrates That BST-CarGel Treatment Improves Structural and Cellular Characteristics of Cartilage Repair Tissue Compared With Microfracture

    PubMed Central

    Méthot, Stéphane; Changoor, Adele; Tran-Khanh, Nicolas; Hoemann, Caroline D.; Stanish, William D.; Restrepo, Alberto; Shive, Matthew S.; Buschmann, Michael D.

    2016-01-01

    Objective The efficacy and safety of BST-CarGel, a chitosan-based medical device for cartilage repair, was compared with microfracture alone at 1 year during a multicenter randomized controlled trial (RCT) in the knee. The quality of repair tissue of osteochondral biopsies collected from a subset of patients was compared using blinded histological assessments. Methods The international RCT evaluated repair tissue quantity and quality by 3-dimensional quantitative magnetic resonance imaging as co-primary endpoints at 12 months. At an average of 13 months posttreatment, 21/41 BST-CarGel and 17/39 microfracture patients underwent elective second look arthroscopies as a tertiary endpoint, during which ICRS (International Cartilage Repair Society) macroscopic scoring was carried out, and osteochondral biopsies were collected. Stained histological sections were evaluated by blinded readers using ICRS I and II histological scoring systems. Collagen organization was evaluated using a polarized light microscopy score. Results BST-CarGel treatment resulted in significantly better ICRS macroscopic scores (P = 0.0002) compared with microfracture alone, indicating better filling, integration, and tissue appearance. Histologically, BST-CarGel resulted in a significant improvement of structural parameters—Surface Architecture (P = 0.007) and Surface/Superficial Assessment (P = 0.042)—as well as cellular parameters—Cell Viability (P = 0.006) and Cell Distribution (P = 0.032). No histological parameters were significantly better for the microfracture group. BST-CarGel treatment also resulted in a more organized repair tissue with collagen stratification more similar to native hyaline cartilage, as measured by polarized light microscopy scoring (P = 0.0003). Conclusion Multiple and independent analyses in this biopsy substudy demonstrated that BST-CarGel treatment results in improved structural and cellular characteristics of repair tissue at 1 year posttreatment compared with

  7. Choosing between NSAID and arnica for topical treatment of hand osteoarthritis in a randomised, double-blind study.

    PubMed

    Widrig, Reto; Suter, Andy; Saller, Reinhard; Melzer, Jörg

    2007-04-01

    The use of topical preparations for symptom relief is common in osteoarthritis. The effects of ibuprofen (5%) and arnica (50 g tincture/100 g, DER 1:20), as gel preparations in patients with radiologically confirmed and symptomatically active osteoarthritis of interphalangeal joints of hands, were evaluated in a randomised, double-blind study in 204 patients, to ascertain differences in pain relief and hand function after 21 days' treatment. Diagnosis was according to established criteria; primary endpoints were pain intensity and hand function; statistical design was as per current regulatory guidelines for testing topical preparations. There were no differences between the two groups in pain and hand function improvements, or in any secondary end points evaluated. Adverse events were reported by six patients (6.1%) on ibuprofen and by five patients (4.8%) on arnica. Our results confirm that this preparation of arnica is not inferior to ibuprofen when treating osteoarthritis of hands.

  8. Biocompatibility of a Sonicated Silk Gel for Cervical Injection During Pregnancy

    PubMed Central

    Critchfield, Agatha S.; Mccabe, Reid; Klebanov, Nikolai; Richey, Lauren; Socrate, Simona; Norwitz, Errol R.; Kaplan, David L.; House, Michael

    2014-01-01

    Objective: To evaluate the biocompatibility of silk gel for cervical injection. Study Design: Silk gel was injected into the cervix of pregnant rats on day 13 (n = 11) and harvested at day 17. Histology of silk gel was compared with suture controls. Also, human cervical fibroblasts were cultured on silk gel and tissue culture plastic (TCP) in vitro. Cell viability, proliferation, metabolic activity, gene expression (COL1A1, COL3A1, and COX2), and release of proinflammatory mediators (interleukin [IL] 6 and IL-8) were evaluated. Results: In vivo, a mild foreign body response was seen surrounding the silk gel and suture controls. In vitro, cervical fibroblasts were viable, metabolically active, and proliferating at 72 hours. Release of IL-6 and IL-8 was similar on silk gel and TCP. Collagen and COX2 gene expression was similar or slightly decreased compared with TCP. Conclusions: Silk gel was well tolerated in vivo and in vitro, which supports continuing efforts to develop silk gels as an alternative to cervical cerclage. PMID:24520079

  9. Supramolecular Gel-Templated In Situ Synthesis and Assembly of CdS Quantum Dots Gels

    NASA Astrophysics Data System (ADS)

    Zhu, Lili; He, Jie; Wang, Xiaoliang; Li, Dawei; He, Haibing; Ren, Lianbing; Jiang, Biwang; Wang, Yong; Teng, Chao; Xue, Gi; Tao, Huchun

    2017-01-01

    Although many studies have attempted to develop strategies for spontaneously organizing nanoparticles (NPs) into three-dimensional (3D) geometries, it remains a fascinating challenge. In this study, a method for in situ synthesis and self-assembly of a CdS quantum dots (QDs) gel using a Cd supramolecular gel as a scaffold was demonstrated. During the QDs formation process, the Cd ions that constituted the Cd gels served as the precursors of the CdS QDs, and the oleic acid (OA) that ligated with the Cd in the supramolecular gels was capped on the surface of the CdS QDs in the form of carboxylate. The OA-stabilized CdS QDs were in situ synthesized in the entangled self-assembled fibrillar networks (SAFIN) of the Cd gels through reactions between the gelator and H2S. As a result, the QDs exactly replicated the framework of the SAFIN in the CdS QD gels instead of simply assembling along the SAFIN of the supramolecular gels. Moreover, the CdS QDs showed extraordinary sensitivity in the fluorescence detection of IO4 - anions. The facile one-step method developed here is a new approach to assembling nanostructured materials into 3D architectures and has general implications for the design of low molecular mass gelators to bring desired functionality to the developed supramolecular gels.

  10. Studies of matrix vesicle-induced mineralization in a gelatin gel

    NASA Technical Reports Server (NTRS)

    Boskey, A. L.; Boyan, B. D.; Doty, S. B.; Feliciano, A.; Greer, K.; Weiland, D.; Swain, L. D.; Schwartz, Z.

    1992-01-01

    Matrix vesicles isolated from fourth-passage cultures of chondrocytes were tested for their ability to induce hydroxyapatite formation in a gelatin gel in order to gain insight into the function of matrix vesicles in in situ mineralization. These matrix vesicles did not appear to be hydroxyapatite nucleators per se since the extent of mineral accumulation in the gel diffusion system was not altered by the presence of matrix vesicles alone, and in the vesicle containing gels, mineral crystals were formed whether associated with vesicles or not. In gels with these matrix vesicles and beta-glycerophosphate, despite the presence of alkaline phosphatase activity, there was no increase in mineral deposition. This suggested that in the gel system these culture-derived vesicles did not increase local phosphate concentrations. However, when known inhibitors of mineral crystal formation and growth (proteoglycan aggregates [4 mg/ml], or ATP [1 mM], or both proteoglycan and ATP) were included in the gel, more mineral was deposited in gels with the vesicles than in comparable gels without vesicles, indicating that enzymes within these vesicles were functioning to remove the inhibition. These data support the suggestion that one function of the extracellular matrix vesicles is to transport enzymes for matrix modification.

  11. Characterization of Detonation Products of RSI-007 Explosive

    NASA Astrophysics Data System (ADS)

    Ager, Timothy; Neel, Christopher; Chhabildas, Lalit

    2011-06-01

    PDV and VISAR have been employed to characterize the detonation products of a production quality RSI-007 explosive. The explosive was part of an exploding foil initiator (EFI) detonator assembly in which the explosive was contained within a Kovar (Fe-Ni-Co alloy) cup. The free surface of the Kovar serves as the witness plate for the interferometry measurements. Detailed shock reverberations are recorded on the witness plate and the isentropic release path of the explosive is inferred though the velocity history. Two separate window materials are bonded to the Kovar cup in subsequent experiments and are used to further determine the release state in different pressure regimes. Presenter

  12. Cumulative irritation potential of metronidazole gel compared to azelaic acid gel after repeated applications to healthy skin.

    PubMed

    Ziel, Kristin; Yelverton, Christopher B; Balkrishnan, Rajesh; Feldman, Steven R

    2005-01-01

    Metronidazole 0.75% gel and azelaic acid 15% gel are commonly used to treat rosacea. Irritation is a common side effect. To assess the cumulative irritation potential of metronidazole 0.75% gel and azelaic acid 15% gel. Metronidazole 0.75% gel, azelaic acid 15% gel, and a white petrolatum negative control were applied under occlusive conditions to the upper back of a total of 33 healthy subjects. There were twelve 24-hour applications (4 times a week) and three 72-hour applications on weekends during a 3-week period. Skin reactions (erythema score +/- other local reaction) were assessed within 15 to 30 minutes of removal of the products. The mean cumulative irritancy index of metronidazole 0.75% gel was significantly lower than that of azelaic acid 15% gel and not significantly higher than the negative control product. There was increasing cumulative irritancy with azelaic acid; no cumulative irritancy was seen for either metronidazole or white petrolatum. Metronidazole 0.75% gel is less irritating in sustained use than azelaic acid 15% gel.

  13. Radiation-Responsive Esculin-Derived Molecular Gels as Signal Enhancers for Optical Imaging.

    PubMed

    Silverman, Julian R; Zhang, Qize; Pramanik, Nabendu B; Samateh, Malick; Shaffer, Travis M; Sagiri, Sai Sateesh; Grimm, Jan; John, George

    2017-12-13

    Recent interest in detecting visible photons that emanate from interactions of ionizing radiation (IR) with matter has spurred the development of multifunctional materials that amplify the optical signal from radiotracers. Tailored stimuli-responsive systems may be paired with diagnostic radionuclides to improve surgical guidance and aid in detecting therapeutic radionuclides otherwise difficult to image with conventional nuclear medicine approaches. Because light emanating from these interactions is typically low in intensity and blue-weighted (i.e., greatly scattered and absorbed in vivo), it is imperative to increase or shift the photon flux for improved detection. To address this challenge, a gel that is both scintillating and fluorescent is used to enhance the optical photon output in image mapping for cancer imaging. Tailoring biobased materials to synthesize thixotropic thermoreversible hydrogels (a minimum gelation concentration of 0.12 wt %) offers image-aiding systems which are not only functional but also potentially economical, safe, and environmentally friendly. These robust gels (0.66 wt %, ∼900 Pa) respond predictably to different types of IRs including β- and γ-emitters, resulting in a doubling of the detectable photon flux from these emitters. The synthesis and formulation of such a gel are explored with a focus on its physicochemical and mechanical properties, before being utilized to enhance the visible photon flux from a panel of radionuclides as detected. The possibility of developing a topical cream of this gel makes this system an attractive potential alternative to current techniques, and the multifunctionality of the gelator may serve to inspire future next-generation materials.

  14. Agar/gelatin bilayer gel matrix fabricated by simple thermo-responsive sol-gel transition method.

    PubMed

    Wang, Yifeng; Dong, Meng; Guo, Mengmeng; Wang, Xia; Zhou, Jing; Lei, Jian; Guo, Chuanhang; Qin, Chaoran

    2017-08-01

    We present a simple and environmentally-friendly method to generate an agar/gelatin bilayer gel matrix for further biomedical applications. In this method, the thermally responsive sol-gel transitions of agar and gelatin combined with the different transition temperatures are exquisitely employed to fabricate the agar/gelatin bilayer gel matrix and achieve separate loading for various materials (e.g., drugs, fluorescent materials, and nanoparticles). Importantly, the resulting bilayer gel matrix provides two different biopolymer environments (a polysaccharide environment vs a protein environment) with a well-defined border, which allows the loaded materials in different layers to retain their original properties (e.g., magnetism and fluorescence) and reduce mutual interference. In addition, the loaded materials in the bilayer gel matrix exhibit an interesting release behavior under the control of thermal stimuli. Consequently, the resulting agar/gelatin bilayer gel matrix is a promising candidate for biomedical applications in drug delivery, controlled release, fluorescence labeling, and bio-imaging. Copyright © 2017 Elsevier B.V. All rights reserved.

  15. Characterization of UC781-Tenofovir Combination Gel Products for HIV-1 Infection Prevention in an Ex Vivo Ectocervical Model

    PubMed Central

    Cost, Marilyn; Dezzutti, Charlene S.; Clark, Meredith R.; Friend, David R.; Akil, Ayman

    2012-01-01

    HIV continues to be a problem worldwide. Topical vaginal microbicides represent one option being evaluated to stop the spread of HIV. With drug candidates that have a specific action against HIV now being studied, it is important that, when appropriate and based on the mechanism of action, the drug permeates the tissue so that it can be delivered to specific targets which reside there. Novel formulations of the nucleotide reverse transcriptase inhibitor tenofovir (TFV) and the nonnucleoside reverse transcriptase inhibitor UC781 have been developed and evaluated here. Gels with three distinct rheological properties were prepared. The three gels released both UC781 and TFV under in vitro conditions at concentrations equal to or above the reported 50% effective concentrations (EC50s). The drug concentrations in ectocervical tissues were well in excess of the reported EC50s. The gels maintain ectocervical viability and prevent infection of ectocervical explants after a HIV-1 challenge. This study successfully demonstrates the feasibility of using this novel combination of antiretroviral agents in an aqueous gel as an HIV infection preventative. PMID:22430977

  16. Thixotropic gel for vadose zone remediation

    DOEpatents

    Riha, Brian D.

    2012-07-03

    A thixotropic gel suitable for use in subsurface bioremediation is provided along with a process of using the gel. The thixotropic gel provides a non-migrating injectable substrate that can provide below ground barrier properties. In addition, the gel components provide for a favorable environment in which certain contaminants are preferentially sequestered in the gel and subsequently remediated by either indigenous or introduced microorganisms.

  17. Thixotropic gel for vadose zone remediation

    DOEpatents

    Rhia, Brian D [Augusta, GA

    2011-03-01

    A thixotropic gel suitable for use in subsurface bioremediation is provided along with a process of using the gel. The thixotropic gel provides a non-migrating injectable substrate that can provide below ground barrier properties. In addition, the gel components provide for a favorable environment in which certain contaminants are preferentially sequestered in the gel and subsequently remediated by either indigenous or introduced microorganisms.

  18. Thixotropic gel for vadose zone remediation

    DOEpatents

    Riha, Brian D.; Looney, Brian B.

    2015-10-27

    A thixotropic gel suitable for use in subsurface bioremediation is provided along with a process of using the gel. The thixotropic gel provides a non-migrating injectable substrate that can provide below ground barrier properties. In addition, the gel components provide for a favorable environment in which certain contaminants are preferentially sequestered in the gel and subsequently remediated by either indigenous or introduced microorganisms.

  19. Microemulsion-loaded hydrogel formulation of butenafine hydrochloride for improved topical delivery.

    PubMed

    Pillai, Anilkumar B; Nair, Jyothilaksmi V; Gupta, Nishant Kumar; Gupta, Swati

    2015-09-01

    Topical microemulsion systems for the antifungal drug, butenafine hydrochloride (BTF) were designed and developed to overcome the problems associated with the cutaneous delivery due to poor water solubility. The solubility of BTF in oils, surfactants and co-surfactants was evaluated to screen the components of the microemulsion. Isopropyl palmitate was used as the oil phase, aerosol OT as the surfactant and sorbitan monooleate as co-surfactant. The pseudoternary diagrams were constructed to identify the area of microemulsion existence and optimum systems were designed. The systems were assessed for drug-loading efficiency and characterized for pH, robustness to dilution, globule size, drug content and stability. Viscosity analysis, spreadability, drug content assay, ex vivo skin permeation study and antifungal activity assay were performed for the optimized microemulsion-loaded hydrogel. The optimized BTF microemulsion had a small and uniform globule size. The incorporation of microemulsion system into Carbopol 940 gel was found to be better as compared to sodium alginate or hydroxyl propyl methyl cellulose (HPMC K4 M) gel. The developed gel has shown better ex vivo skin permeation and antifungal activity when compared to marketed BTF cream. Thus, the results provide a basis for the successful delivery of BTF from microemulsion-loaded hydrogel formulation, which resulted in improved penetration of drug and antifungal activity in comparison with commercial formulation of BTF.

  20. Topic modeling for cluster analysis of large biological and medical datasets

    PubMed Central

    2014-01-01

    Background The big data moniker is nowhere better deserved than to describe the ever-increasing prodigiousness and complexity of biological and medical datasets. New methods are needed to generate and test hypotheses, foster biological interpretation, and build validated predictors. Although multivariate techniques such as cluster analysis may allow researchers to identify groups, or clusters, of related variables, the accuracies and effectiveness of traditional clustering methods diminish for large and hyper dimensional datasets. Topic modeling is an active research field in machine learning and has been mainly used as an analytical tool to structure large textual corpora for data mining. Its ability to reduce high dimensionality to a small number of latent variables makes it suitable as a means for clustering or overcoming clustering difficulties in large biological and medical datasets. Results In this study, three topic model-derived clustering methods, highest probable topic assignment, feature selection and feature extraction, are proposed and tested on the cluster analysis of three large datasets: Salmonella pulsed-field gel electrophoresis (PFGE) dataset, lung cancer dataset, and breast cancer dataset, which represent various types of large biological or medical datasets. All three various methods are shown to improve the efficacy/effectiveness of clustering results on the three datasets in comparison to traditional methods. A preferable cluster analysis method emerged for each of the three datasets on the basis of replicating known biological truths. Conclusion Topic modeling could be advantageously applied to the large datasets of biological or medical research. The three proposed topic model-derived clustering methods, highest probable topic assignment, feature selection and feature extraction, yield clustering improvements for the three different data types. Clusters more efficaciously represent truthful groupings and subgroupings in the data than

  1. Topic modeling for cluster analysis of large biological and medical datasets.

    PubMed

    Zhao, Weizhong; Zou, Wen; Chen, James J

    2014-01-01

    The big data moniker is nowhere better deserved than to describe the ever-increasing prodigiousness and complexity of biological and medical datasets. New methods are needed to generate and test hypotheses, foster biological interpretation, and build validated predictors. Although multivariate techniques such as cluster analysis may allow researchers to identify groups, or clusters, of related variables, the accuracies and effectiveness of traditional clustering methods diminish for large and hyper dimensional datasets. Topic modeling is an active research field in machine learning and has been mainly used as an analytical tool to structure large textual corpora for data mining. Its ability to reduce high dimensionality to a small number of latent variables makes it suitable as a means for clustering or overcoming clustering difficulties in large biological and medical datasets. In this study, three topic model-derived clustering methods, highest probable topic assignment, feature selection and feature extraction, are proposed and tested on the cluster analysis of three large datasets: Salmonella pulsed-field gel electrophoresis (PFGE) dataset, lung cancer dataset, and breast cancer dataset, which represent various types of large biological or medical datasets. All three various methods are shown to improve the efficacy/effectiveness of clustering results on the three datasets in comparison to traditional methods. A preferable cluster analysis method emerged for each of the three datasets on the basis of replicating known biological truths. Topic modeling could be advantageously applied to the large datasets of biological or medical research. The three proposed topic model-derived clustering methods, highest probable topic assignment, feature selection and feature extraction, yield clustering improvements for the three different data types. Clusters more efficaciously represent truthful groupings and subgroupings in the data than traditional methods, suggesting

  2. The efficacy of 5% dapsone gel plus oral isotretinoin versus oral isotretinoin alone in acne vulgaris: A randomized double-blind study

    PubMed Central

    Faghihi, Gita; Rakhshanpour, Mehrdad; Abtahi-Naeini, Bahareh; Nilforoushzadeh, Mohammad Ali

    2014-01-01

    Background: Acne vulgaris, a common human skin condition, is an inflammatory disease characterized by comedones, papules, nodules and possibly scarring. This study aimed to evaluate the efficacy of a combination of 5% dapsone gel plus oral isotretinoin in the treatment of acne vulgaris. Materials and Methods: A randomized, placebo-controlled, study was carried out on patients with moderate to severe acne. The patients were randomly divided in two groups: (dapsone gel and vehicle gel). All Patients were administered oral isotretinoin 20 mg daily and topical gel twice a day for 8 weeks. The Global Acne Assessment Score (GAAS), the number lesions and side-effects were documented at base line and weeks 4, 8 and 12. Results: A total of 58 patients (age range: 18-25 years) were included in our study. The number of lesions was significantly lower in the dapsone-treated group at all follow-up visits (P < 0.001). The mean GAAS score in the dapsone-treated group and in the Placebo-treated group decreased, but there was no statistical difference in two groups (P < 0.001). The side-effects on the dapsone-treated group were a mild burning sensation in 7 patients (24.13%), mild erythema of the skin and mild dryness in 4 (13.79%) and 3 (10.34%) cases respectively (P < 0.001). In our study, adverse effects were common but they were minor and tolerable. No clinically significant changes in laboratory parameters were observed (P < 0.001). Conclusions: Dapsone gel was an effective medication for patients who received isotretinoin for acne vulgaris treatment resulting in a significant reduction of the number of lesions. PMID:25250291

  3. Sol-Gel Manufactured Energetic Materials

    DOEpatents

    Simpson, Randall L.; Lee, Ronald S.; Tillotson, Thomas M.; Hrubesh, Lawrence W.; Swansiger, Rosalind W.; Fox, Glenn A.

    2005-05-17

    Sol-gel chemistry is used for the preparation of energetic materials (explosives, propellants and pyrotechnics) with improved homogeneity, and/or which can be cast to near-net shape, and/or made into precision molding powders. The sol-gel method is a synthetic chemical process where reactive monomers are mixed into a solution, polymerization occurs leading to a highly cross-linked three dimensional solid network resulting in a gel. The energetic materials can be incorporated during the formation of the solution or during the gel stage of the process. The composition, pore, and primary particle sizes, gel time, surface areas, and density may be tailored and controlled by the solution chemistry. The gel is then dried using supercritical extraction to produce a highly porous low density aerogel or by controlled slow evaporation to produce a xerogel. Applying stress during the extraction phase can result in high density materials. Thus, the sol-gel method can be used for precision detonator explosive manufacturing as well as producing precision explosives, propellants, and pyrotechnics, along with high power composite energetic materials.

  4. Sol-gel manufactured energetic materials

    DOEpatents

    Simpson, Randall L.; Lee, Ronald S.; Tillotson, Thomas M.; Hrubesh, Lawrence W.; Swansiger, Rosalind W.; Fox, Glenn A.

    2003-12-23

    Sol-gel chemistry is used for the preparation of energetic materials (explosives, propellants and pyrotechnics) with improved homogeneity, and/or which can be cast to near-net shape, and/or made into precision molding powders. The sol-gel method is a synthetic chemical process where reactive monomers are mixed into a solution, polymerization occurs leading to a highly cross-linked three dimensional solid network resulting in a gel. The energetic materials can be incorporated during the formation of the solution or during the gel stage of the process. The composition, pore, and primary particle sizes, gel time, surface areas, and density may be tailored and controlled by the solution chemistry. The gel is then dried using supercritical extraction to produce a highly porous low density aerogel or by controlled slow evaporation to produce a xerogel. Applying stress during the extraction phase can result in high density materials. Thus, the sol-gel method can be used for precision detonator explosive manufacturing as well as producing precision explosives, propellants, and pyrotechnics, along with high power composite energetic materials.

  5. Topical Effects of Artemisia Absinthium Ointment and Liniment in Comparison with Piroxicam Gel in Patients with Knee Joint Osteoarthritis: A Randomized Double-Blind Controlled Trial

    PubMed Central

    Basiri, Zahra; Zeraati, Fatemeh; Esna-Ashari, Farzaneh; Mohammadi, Farshid; Razzaghi, Keyvan; Araghchian, Malihe; Moradkhani, Shirin

    2017-01-01

    Background: Pain alleviation and improvement of functional status are the main objectives in the treatment of osteoarthritis. Artemisia absinthium (AA) was used traditionally in reducing pain and inflammation. The aim of the present study was to compare the effects of topical formulations of AA and piroxicam gel (PG) among patients with knee osteoarthritis. Methods: In total, 90 outpatients aged 30-70 years with the diagnosis of primary osteoarthritis in at least one knee were enrolled in a randomized double-blind clinical trial. The patients referred to the Rheumatology Clinic at Shahid Beheshti Hospital in Hamadan province during 2012-2013. The patients were randomly assigned into three groups, 30 patients per group, and respectively received AA ointment (AAO) 3%, AA liniment (AAL) 3%, and PG; three times daily (TID) for 4 weeks. The patients were visited at baseline, week 4, and week 6. The effectiveness criteria were pain severity which was assessed with a 10-point visual analog scale (VAS), the Western Ontario and McMaster Universities osteoarthritis index (WOMAC) for total pain score (WTPS), total physical function score (WTPFS), and total stiffness score (WTSS). Repeated measure ANOVA, paired t test and post hoc were used to compare variables. Statistical analysis was performed using the SPSS software, version 13.0 (SPSS Inc., Chicago, Illinois). Results: All groups had similar patient demographics. The administration of PG significantly improved all tested criteria with no recurrence after discontinuing the treatment protocol. AAO alleviated all tested factors except for WTSS. Alleviation was comparable to PG. AAL only reduced pain factors (VAS, WTPS) in week 4 with recurrence in week 6. Conclusion: Administration of Artemisia ointment may have beneficial effects in the treatment of osteoarthritis. Trial Registration Number: IRCT201202123109N3 PMID:29184260

  6. Topical Effects of Artemisia Absinthium Ointment and Liniment in Comparison with Piroxicam Gel in Patients with Knee Joint Osteoarthritis: A Randomized Double-Blind Controlled Trial.

    PubMed

    Basiri, Zahra; Zeraati, Fatemeh; Esna-Ashari, Farzaneh; Mohammadi, Farshid; Razzaghi, Keyvan; Araghchian, Malihe; Moradkhani, Shirin

    2017-11-01

    Pain alleviation and improvement of functional status are the main objectives in the treatment of osteoarthritis. Artemisia absinthium (AA) was used traditionally in reducing pain and inflammation. The aim of the present study was to compare the effects of topical formulations of AA and piroxicam gel (PG) among patients with knee osteoarthritis. In total, 90 outpatients aged 30-70 years with the diagnosis of primary osteoarthritis in at least one knee were enrolled in a randomized double-blind clinical trial. The patients referred to the Rheumatology Clinic at Shahid Beheshti Hospital in Hamadan province during 2012-2013. The patients were randomly assigned into three groups, 30 patients per group, and respectively received AA ointment (AAO) 3%, AA liniment (AAL) 3%, and PG; three times daily (TID) for 4 weeks. The patients were visited at baseline, week 4, and week 6. The effectiveness criteria were pain severity which was assessed with a 10-point visual analog scale (VAS), the Western Ontario and McMaster Universities osteoarthritis index (WOMAC) for total pain score (WTPS), total physical function score (WTPFS), and total stiffness score (WTSS). Repeated measure ANOVA, paired t test and post hoc were used to compare variables. Statistical analysis was performed using the SPSS software, version 13.0 (SPSS Inc., Chicago, Illinois). All groups had similar patient demographics. The administration of PG significantly improved all tested criteria with no recurrence after discontinuing the treatment protocol. AAO alleviated all tested factors except for WTSS. Alleviation was comparable to PG. AAL only reduced pain factors (VAS, WTPS) in week 4 with recurrence in week 6. Administration of Artemisia ointment may have beneficial effects in the treatment of osteoarthritis. Trial Registration Number: IRCT201202123109N3.

  7. Systemic exposure to benzoic acid and hippuric acid following topical application of clindamycin 1%/benzoyl peroxide 3% fixed-dose combination gel in Japanese patients with acne vulgaris.

    PubMed

    Ino, Hiroko; Takahashi, Naoki; Saenz, Alessandra Alio; Wakamatsu, Akira; Hashimoto, Hirofumi; Nakahara, Norie; Hasegawa, Setsuo

    2015-01-01

    Clindamycin 1%/benzoyl peroxide 3% fixed-dose combination gel (CLDM/BPO3%) is a topical product for the treatment of acne vulgaris. In this study, plasma and urine concentrations of benzoic acid (BA) and hippuric acid (HA) were analyzed to estimate the pharmacokinetics (PK) of BPO after application of CLDM/BPO3% twice-daily for 7 days in Japanese patients with acne vulgaris. Seven-day repeated application of CLDM/BPO3% appears to be safe in this patient population. Concentrations of plasma and urine BA were below the limit of quantification before and after repeated application in most of the 12 adult male patients. Mean difference in Cmax and AUC0-last for plasma HA indicated increased exposures after repeated application, but with wide 90% confidence intervals. Mean Ae0-12 for urine HA was similar before and after repeated application. Repeated application of CLDM/BPO3% is thus unlikely to result in accumulation of BA and HA. The study suggests negligible systemic exposure to BPO metabolites from CLDM/BPO3% after 7-day repeated application in male patients with acne vulgaris. © 2014, The American College of Clinical Pharmacology.

  8. Orientation of chain molecules in ionotropic gels: a Brownian dynamics model

    NASA Astrophysics Data System (ADS)

    Woelki, Stefan; Kohler, Hans-Helmut

    2003-09-01

    As is known from birefringence measurements, polysaccharide molecules of ionotropic gels are preferentially orientated normal to the direction of gel growth. In this paper the orientation effect is investigated by means of an off-lattice Brownian dynamics model simulating the gel formation process. The model describes the integration of a single coarse grained phantom chain into the growing gel. The equations of motion of the chain are derived. The computer simulations show that, during the process of integration, the chain is contracting normal to the direction of gel growth. A scaling relation is obtained for the degree of contraction as a function of the length parameters of the chain, the velocity of the gel formation front and the rate constant of the crosslinking reaction. It is shown that the scaling relation, if applied to the example of ionotropic copper alginate gel, leads to reasonable predictions of the time course of the degree of contraction of the alginate chains.

  9. Oscillation of a polymer gel entrained with a periodic force.

    PubMed

    Shiota, Takaya; Ikura, Yumihiko S; Nakata, Satoshi

    2013-02-21

    The oscillation of a polymer gel induced by the Belousov-Zhabotinsky (BZ) reaction was investigated under an external force composed of a square wave. The oscillation of the BZ reaction entrained to the periodic force and the features of this entrainment changed depending on the period and duty cycle of the square wave. The experimental results suggest that the change in the volume of the gel also gave feedback to the BZ reaction. The mechanism of entrainment is discussed in relation to the compression of the gel and the reaction-diffusion system in the BZ reaction.

  10. Treatment adherence and real-life effectiveness of topical therapy in patients with mild or moderate psoriasis: uptake of scientific evidence in clinical practice and dermatologists' preferences for alternative treatment options.

    PubMed

    Neri, L; Miracapillo, A

    2015-02-01

    Topical corticosteroids and the vitamin D analogue calcipotriol are the cornerstone of therapy for patients with mild-to-moderate plaque psoriasis. Lack of patients' adherence leads to suboptimal effectiveness of topical therapy in real-life practice. The fixed combination betamethasone/calcipotriol gel is more effective and safe than the administration of single components and may enhance patients' adherence. We aimed at evaluating the pattern of care and dermatologists' expert opinion toward the available topical treatments for the management of mild-to-moderate psoriasis in Italy. We enrolled 242 Italian dermatologists and collected information related to their practice pattern and opinion toward available topical treatments with a face-to-face structured interview. We evaluated dermatologists' ratings of therapy with 16 items tapping their opinion toward the relevance and satisfaction toward 8 therapy attributes in clinical practices which tapped aspects of real-life effectiveness, adherence promotion, toxicity, convenience of use. Ratings occurred along a 10-point scale. We compared single-attribute and weighted overall therapy ratings across alternative treatment options with random-intercept linear models to account for ratings clustering within dermatologists. There was a wide variation in practice patterns: 1/3 of dermatologist had seen more than 30 patients with psoriasis while around 1/4 had seen less than 10 patients. The fixed combination betamethasone/calcipotriol gel was considered superior to monotherapies in all the eight attributes considered which tapped aspects of real-life effectiveness, adherence promotion, toxicity, convenience of use. Participant dermatologists' strongly preferred the fixed betamethasone/calcipotriol combination gel over both the fixed combination ointment formulation and corticosteroid or vitamin D analogues monotherapies. Such findings are in line with evidence from randomized controlled trials and few observational

  11. Influence of pre-cooking protein paste gelation conditions and post-cooking gel storage conditions on gel texture.

    PubMed

    Paker, Ilgin; Matak, Kristen E

    2016-01-15

    Gelation conditions affect the setting of myofibrillar fish protein gels. Therefore the impact of widely applied pre-cooking gelation time/temperature strategies and post-cooking period on the texture and color of final protein gels was determined. Four pre-cooking gelation strategies (no setting time, 30 min at 25 °C, 1 h at 40 °C or 24 h at 4 °C) were applied to protein pastes (fish protein concentrate and standard functional additives). After cooking, texture and color were analyzed either directly or after 24 h at 4 °C on gels adjusted to 25 °C. No-set gels were harder, gummier and chewier (P < 0.05) when analyzed immediately after cooling; however, gel chewiness, cohesiveness and firmness indicated by Kramer force benefited from 24 h at 4 °C gel setting when stored post-cooking. Gel-setting conditions had a greater (P < 0.05) effect on texture when directly analyzed and most changes occurred in no-set gels. There were significant (P < 0.05) changes between directly analyzed and post-cooking stored gels in texture and color, depending on the pre-cooking gelation strategy. Pre-cooking gelation conditions will affect final protein gel texture and color, with gel stability benefiting from a gel-setting period. However, post-cooking storage may have a greater impact on final gels, with textural attributes becoming more consistent between all samples. © 2015 Society of Chemical Industry.

  12. Clinical efficacy of new aloe vera- and myrrh-based oral mucoadhesive gels in the management of minor recurrent aphthous stomatitis: a randomized, double-blind, vehicle-controlled study.

    PubMed

    Mansour, Ghada; Ouda, Soliman; Shaker, Ahmed; Abdallah, Hossam M

    2014-07-01

    To evaluate the clinical efficacy, and safety of newly customized natural oral mucoadhesive gels, containing either aloe vera or myrrh as active ingredients, in the management of minor recurrent aphthous stomatitis (MiRAS). Ninety subjects with MiRAS were recruited from Oral Medicine Clinic, at Faculty of Dentistry, King Abdulaziz University, Saudi Arabia, for this randomized, double-blind, placebo-controlled study. Two new natural gels, containing aloe vera and myrrh, were prepared in a concentration of (0.5% w/w), in addition to a plain mucoadhesive gel used as a placebo. Patients with fresh ulcers (<48-h duration) were instructed to apply either one of the three gels four times a day for a period of 5 days. Clinical efficacy was investigated in the form of changes in ulcer size, pain intensity, erythema, and exudation at days 4 and 6 of study entry. Participants were interviewed for the emergence of any side effects. 76.6% of patients using aloe gel showed complete ulcer healing, 86.7%, and 80% of them revealed subsidence of erythema and exudation, respectively, especially at day 6 visit, whereas 76.7% of myrrh-treated patients revealed almost absence of pain at day 6. No side effects were encountered with the use of any of the three gels. The new formulated aloe- and myrrh-based gels proved to be effective in topical management of MiRAS. Aloe was superior in decreasing ulcer size, erythema, and exudation; whereas myrrh resulted in more pain reduction. © 2013 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  13. 40 CFR 86.007-15 - NOX and particulate averaging, trading, and banking for heavy-duty engines.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ..., and banking for heavy-duty engines. 86.007-15 Section 86.007-15 Protection of Environment... Light-Duty Vehicles, Light-Duty Trucks and Heavy-Duty Engines, and for 1985 and Later Model Year New Gasoline Fueled, Natural Gas-Fueled, Liquefied Petroleum Gas-Fueled and Methanol-Fueled Heavy-Duty Vehicles...

  14. Topical ketoprofen nanogel: artificial neural network optimization, clustered bootstrap validation, and in vivo activity evaluation based on longitudinal dose response modeling.

    PubMed

    Elkomy, Mohammed H; Elmenshawe, Shahira F; Eid, Hussein M; Ali, Ahmed M A

    2016-11-01

    This work aimed at investigating the potential of solid lipid nanoparticles (SLN) as carriers for topical delivery of Ketoprofen (KP); evaluating a novel technique incorporating Artificial Neural Network (ANN) and clustered bootstrap for optimization of KP-loaded SLN (KP-SLN); and demonstrating a longitudinal dose response (LDR) modeling-based approach to compare the activity of topical non-steroidal anti-inflammatory drug formulations. KP-SLN was fabricated by a modified emulsion/solvent evaporation method. Box-Behnken design was implemented to study the influence of glycerylpalmitostearate-to-KP ratio, Tween 80, and lecithin concentrations on particle size, entrapment efficiency, and amount of drug permeated through rat skin in 24 hours. Following clustered bootstrap ANN optimization, the optimized KP-SLN was incorporated into an aqueous gel and evaluated for rheology, in vitro release, permeability, skin irritation and in vivo activity using carrageenan-induced rat paw edema model and LDR mathematical model to analyze the time course of anti-inflammatory effect at various application durations. Lipid-to-drug ratio of 7.85 [bootstrap 95%CI: 7.63-8.51], Tween 80 of 1.27% [bootstrap 95%CI: 0.601-2.40%], and Lecithin of 0.263% [bootstrap 95%CI: 0.263-0.328%] were predicted to produce optimal characteristics. Compared with profenid® gel, the optimized KP-SLN gel exhibited slower release, faster permeability, better texture properties, greater efficacy, and similar potency. SLNs are safe and effective permeation enhancers. ANN coupled with clustered bootstrap is a useful method for finding optimal solutions and estimating uncertainty associated with them. LDR models allow mechanistic understanding of comparative in vivo performances of different topical formulations, and help design efficient dermatological bioequivalence assessment methods.

  15. Diclofenac in hyaluronic acid gel: an alternative treatment for actinic cheilitis

    PubMed Central

    LIMA, Giana da Silveira; da SILVA, Gabriela Ferrari; GOMES, Ana Paula Neutzling; de ARAÚJO, Lenita Maria Aver; SALUM, Fernanda Gonçalves

    2010-01-01

    Objective Actinic cheilitis (AC) is a precancerous lesion of the lip vermillion caused by prolonged exposure to ultraviolet light. The aim of this study was to evaluate the effect of 3% diclofenac in 2.5% hyaluronic acid gel in the treatment of AC. Methods Thirty-four patients with chronic AC were treated twice a day with topical diclofenac during a period of 30 to 180 days. The individuals were followed up every 15 days by means of clinical examination and digital photographic documentation. Results Of the 27 patients that completed the study, 12 (44%) showed complete remission of the whitish plaques and exfoliative areas, and 15 (56%) had partial remission of the clinical picture of cheilitis. The latter group was submitted to excision of the leukoplakic areas which diagnosis varied from mild to moderate epithelial dysplasia. Conclusion The results suggest a promising role for diclofenac in hyaluronic acid gel in the treatment of AC. This treatment has the advantages of not being invasive and showing few side effects. PMID:21085813

  16. A study on electrode gels for skin conductance measurements.

    PubMed

    Tronstad, Christian; Johnsen, Gorm Krogh; Grimnes, Sverre; Martinsen, Ørjan G

    2010-10-01

    Low-frequency skin conductance is used within several clinical applications and is mainly sensitive to sweating and the moisture content of the stratum corneum, but also how electrodes introduce changes in the electrical properties. Four electrode gels were investigated with regard to sorption characteristics and electrical properties. Skin conductance time series were collected from 18 test subjects during relaxation, exercise and recovery, wearing different pairs of electrodes contralaterally on the hypothenar and the T9 dermatome. Pressure test was applied on the T9 electrodes. Impedance frequency sweeps were taken on the T9 electrodes the same day and the next, parameterized to the Cole model. ANOVA on the initial skin conductance level change, exercise response amplitude, recovery offset and pressure-induced changes revealed significant differences among gel types. The wetter gels caused a higher positive level change, a greater response amplitude, larger recovery offset and greater pressure-induced artifacts compared to the solid gels. Sweating on the T9 site led to negative skin conductance responses for the wetter gels. Correlations were found between the desorption measurements and the initial skin conductance level change (hypothenar: R = 0.988 T9: R = 0.901) RM-ANOVA on the Cole parameters revealed a significant decrease in R(s) of the most resistive gel. Clinical implications are discussed.

  17. XEN Gel Implant: a new surgical approach in glaucoma.

    PubMed

    Chaudhary, Ankita; Salinas, Lauriane; Guidotti, Jacopo; Mermoud, André; Mansouri, Kaweh

    2018-01-01

    Glaucoma is a leading cause of blindness worldwide. Intraocular pressure (IOP) lowering is the only effective treatment strategy. Traditional glaucoma surgeries are generally considered to be unpredictable and associated with a high rate of complications. This has led to the development of a novel XEN Gel Implant, a type of minimally invasive glaucoma surgery (MIGS), lowering the IOP without extensive surgical dissection. Areas covered: A literature search was undertaken on PubMed using the terms XEN glaucoma, gelatin microstent, and MIGS. All the articles and case reports on XEN Gel Implant and selected articles on MIGS were studied and reviewed. We have discussed the results of most studies on XEN Gel Implant related to its efficacy, safety and success. Expert commentary: The XEN Gel Implant effectively lowers IOP and medication use, with a favorable safety profile. Long-term data on its success and cost-effectiveness are lacking. The studies have shown it to be without any serious adverse events and to have good safety profile encouraging future research on this novel implant. There is a need to correctly identify selection criteria for patients, who would benefit the most from the XEN Gel Implant.

  18. 40 CFR 86.007-15 - NOX and particulate averaging, trading, and banking for heavy-duty engines.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 40 Protection of Environment 18 2011-07-01 2011-07-01 false NOX and particulate averaging, trading... § 86.007-15 NOX and particulate averaging, trading, and banking for heavy-duty engines. Section 86.007... engines may participate in an NMHC averaging, banking and trading program to show compliance with the...

  19. 46 CFR 159.007-7 - Application for acceptance for production inspections and tests: Coast Guard action.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 46 Shipping 6 2011-10-01 2011-10-01 false Application for acceptance for production inspections and tests: Coast Guard action. 159.007-7 Section 159.007-7 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) EQUIPMENT, CONSTRUCTION, AND MATERIALS: SPECIFICATIONS AND APPROVAL APPROVAL OF EQUIPMENT AND MATERIALS Production Inspection...

  20. 46 CFR 159.007-7 - Application for acceptance for production inspections and tests: Coast Guard action.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 46 Shipping 6 2010-10-01 2010-10-01 false Application for acceptance for production inspections and tests: Coast Guard action. 159.007-7 Section 159.007-7 Shipping COAST GUARD, DEPARTMENT OF HOMELAND SECURITY (CONTINUED) EQUIPMENT, CONSTRUCTION, AND MATERIALS: SPECIFICATIONS AND APPROVAL APPROVAL OF EQUIPMENT AND MATERIALS Production Inspection...

  1. Label-free measurement of microbicidal gel thickness using low-coherence interferometry

    NASA Astrophysics Data System (ADS)

    Braun, Kelly E.; Boyer, Jeffrey D.; Henderson, Marcus H.; Katz, David F.; Wax, Adam

    2006-03-01

    Spectral-domain low-coherence interferometry (LCI) was used to measure the thickness of microbicidal gels applied to a cylindrical calibration test socket. Microbicides are topical formulations containing active ingredients targeted to inhibit specific pathogens that are currently under development for application to the epithelial lining of the lower female reproductive tract to combat sexually transmitted infections such as HIV. Understanding the deployment and drug delivery of these formulations is vital to maximizing their effectiveness. Previously, in vivo measurements of microbicidal formulation thickness were assessed using fluorescence measurements of fluorescein-labeled gels via an optical endoscope-based device. Here we present an LCI-based device that measures the thickness of a formulation without the use of any exogenous agents by analyzing the interference pattern generated between the reflections from the front and back surface of the sample. Results are presented that validate the effectiveness and performance of the LCI measurement in a clinically relevant system as compared to an existing fluorescence-based method. The impact of the new LCI-based design on in vivo measurements is discussed.

  2. Comparison of skin permeability for three diclofenac topical formulations: an in vitro study.

    PubMed

    Folzer, E; Gonzalez, D; Singh, R; Derendorf, H

    2014-01-01

    Diclofenac is a hydrophilic non-steroidal anti-inflammatory drug (NSAID) widely used in humans and animals. There are limited published studies evaluating diclofenac's skin permeation following topical administration. The aim of our study was to evaluate and compare the in vitro permeation of three different diclofenac-containing formulations (patch, gel, solution) over 24 hours. These formulations were applied (n = 6 per formulation) to pig skin sandwiched between the two chambers in a static Franz diffusion cell and aliquots from the receptor medium were sampled at pre-defined time points. An HPLC method with UV detection was developed and validated with the aim of characterizing the transepidermal penetration in the in vitro system. Using this assay to determine the permeation parameters, results at 24 hours showed that the Flector patch released the highest drug amount (54.6%), whereas a lower drug amount was delivered with the Voltaren Emulgel (38.2%) and the solution (34.4%). The commercial gel showed the highest flux (39.9 +/- 0.9 microg/cm2/h) and the shortest lag-time (1.97 +/- 0.02 h). Based on these in vitro results using pig skin, the transdermal patch resulted in a long-lasting controlled release of diclofenac, while the gel had the shortest lag-time.

  3. Development in electrophoresis: instrumentation for two-dimensional gel electrophoresis of protein separation and application of capillary electrophoresis in micro-bioanalysis

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Xu, Aoshuang

    2008-01-01

    This dissertation begins with a general introduction of topics related to this work. The following chapters contain three scientific manuscripts, each presented in a separate chapter with accompanying tables, figures, and literature citations. The final chapter summarizes the work and provides some prospective on this work. This introduction starts with a brief treatment of the basic principles of electrophoresis separation, followed by a discussion of gel electrophoresis and particularly polyacrylamide gel electrophoresis for protein separation, a summary of common capillary electrophoresis separation modes, and a brief treatment of micro-bioanalysis application of capillary electrophoresis, and ends with an overview of proteinmore » conformation and dynamics.« less

  4. Development of an integrated endoscopic device for multiplexed low coherence interferometry measurements of microbicide gel coating thickness

    NASA Astrophysics Data System (ADS)

    Drake, Tyler K.; Robles, Francisco E.; DeSoto, Michael; Henderson, Marcus H.; Katz, David F.; Wax, Adam P.

    2009-02-01

    Microbicide gels are topical products that have recently been developed to combat sexually transmitted diseases including HIV/AIDS. The extent of gel coverage, thickness, and structure are crucial factors in gel effectiveness. It is necessary to be able to monitor gel distribution and behavior under various circumstances, such as coatis, and over an extended time scale in vivo. We have developed a multiplexed, Fourier-domain low coherence interferometry (LCI) system as a practical method of measuring microbicide gel distribution, with precision and accuracy comparable to currently used fluorometric techniques techniques. The multiplexed system achieved a broad scanning area without the need for a mechanical scanning device, typical of OCT systems, by utilizing six parallel channels with simultaneous data collection. We now propose an imaging module which will allow the integration of the multiplexed LCI system into the current fluorescence system in conjunction with an endoscope. The LCI imaging module will meet several key criteria in order to be compatible with the current system. The fluorescent system features a 4-mm diameter rigid endsoscope enclosed in a 27-mm diameter polycarbonate tube, with a water immersion tip. Therefore, the LCI module must be low-profile as well as water-resistant to fit inside the current design. It also must fulfill its primary function of delivering light from each of the six channels to the gel and collecting backscattered light. The performance of the imaging module will be characterized by scanning a calibration socket which contains grooves of known depths, and comparing these measurements to the fluorometric results.

  5. Preparation, Optimization, In vitro Evaluation and Ex vivo Permeation Studies of Finasteride loaded gel Formulations Prepared by using Response Surface Methodology.

    PubMed

    Khan, Muhammad Zia Ullah; Makreski, Petre; Murtaza, Ghulam

    2018-05-02

    The aim of present explorative study was to prepare and optimize finasteride loaded topical gel formulations by using three factor [propylene glycol (PG), Tween® 80, and sodium lauryl sulphate (SLS)], five level central composite design. Optimized finasteride topical gel formulation (F4), containing PG, Tween® 80, and SLS in a concentration of 0.8 mg, 0.4 mg and 0.2 mg, respectively, showed 6-fold higher values of cumulative drug release, flux, partition coefficient, input rate, lag time, and diffusion coefficient, when compared to control formulation without permeation enhancer. Finally, it can be concluded that finasteride permeation was enhanced by PG, tween® 80 and SLS individually, while in combination only PG along with tween® 80 had synergistic and more pronounced effect on flux, permeability coefficient and input rate while antagonistic effect on lag time and diffusion coefficient was observed. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

  6. High transparent shape memory gel

    NASA Astrophysics Data System (ADS)

    Gong, Jin; Arai, Masanori; Kabir, M. H.; Makino, Masato; Furukawa, Hidemitsu

    2014-03-01

    Gels are a new material having three-dimensional network structures of macromolecules. They possess excellent properties as swellability, high permeability and biocompatibility, and have been applied in various fields of daily life, food, medicine, architecture, and chemistry. In this study, we tried to prepare new multi-functional and high-strength gels by using Meso-Decoration (Meso-Deco), one new method of structure design at intermediate mesoscale. High-performance rigid-rod aromatic polymorphic crystals, and the functional groups of thermoreversible Diels-Alder reaction were introduced into soft gels as crosslinkable pendent chains. The functionalization and strengthening of gels can be realized by meso-decorating the gels' structure using high-performance polymorphic crystals and thermoreversible pendent chains. New gels with good mechanical properties, novel optical properties and thermal properties are expected to be developed.

  7. Procedures and computer program for deriving the Ferguson plot from electrophoresis in a single pore gradient gel: application to agarose gel and a polystyrene particle.

    PubMed

    Tietz, D; Gombocz, E; Chrambach, A

    1991-10-01

    This study presents a computerized evaluation of pore gradient gel electrophoretograms to arrive at estimates for both the particle-free mobility and retardation coefficient, which is related to particle size. Agarose pore gradient gels ranging from 0.2 to 1.1% agarose were formed. Gel gradients were stabilized during their formation by a density gradient of 0-20% 5-(N-2,3-dihydroxypropylacetamido)- 2,4,6-triiodo-N,N'bis-(2,3-dihydroxypropyl)-isophthalamide (Nycodenz). Densitometry of gelled-in Bromophenol Blue showed that these pore gradients exhibited a linear central segment and were reproducible. Migration distances of polystyrene sulfate microspheres (36.5 nm radius) in agarose pore gradient gel electrophoresis were determined by time-lapse photography at several durations of electrophoresis. These migration distances were evaluated as a function of migration time as previously reported (D. Tietz, Adv. Electrophoresis 1988, 2, 109-169). Although this is not necessarily required, the mathematical approach used in this study assumed linearity of both the pore gradient and the Ferguson plot for reasons of simplicity. The data evaluation on the basis of the extended Ogston model is incorporated in a user-friendly program, GRADFIT, which is designed for personal computers (Macintosh). The results obtained are compared with (1) conventional electrophoresis using several gels of single concentration with and without Nycodenz, and (ii) a different mathematical approach for the analysis of gradient gels (Rodbard et al., Anal. Biochem. 1971, 40, 135-157). Moreover, a simple procedure for evaluating linear pore gradient gels using linear regression analysis is presented. It is concluded that the values of particle-free mobility and retardation coefficient derived from pore gradient gel electrophoresis using the different mathematical methods are statistically indistinguishable from each other. However, these values are different, albeit close, to those obtained from

  8. [Sniffing Position and i-gel Rotation Approach for i-gel Insertion under General Anesthesia].

    PubMed

    Takahashi, Yoshihiro; Murashima, Koji; Kayashima, Kenji

    2016-04-01

    Insertion assistance techniques, such as the sniffing position (SP) and i-gel? rotation approach (RA), are recommended in the i-gel supraglottic airway device insertion manual. The usefulness of these techniques was evaluated, in this study, under general anesthesia. In 50 adult patients, the i-gel was inserted with the patient in the mild-SP with 5 degrees head extention at first attempt. When resistance was encountered during insertion or airway patency was not obtained after insertion, the i-gel was re-inserted with the patient in the full-SP with maximum head extention during second attempt. When re-insertion failed, the i-gel was inserted with the patient in the full-SP and by using the i-gel RA during third attempt. Airway patency was established in the mild-SP in 36 of 50 patients, in the full-SP in 11 of the remaining 14, and in the full-SP with the i-gel RA in the remaining 3. The average insertion time was 24.0 s during the first attempt, 22.2 s during the second, and 18.2 s during the third. No major complications were observed. Both the full-SP and the i-gel RA can be used for i-gel insertion.

  9. Evolution of heterogeneity accompanying sol-gel transitions in a supramolecular hydrogel.

    PubMed

    Matsumoto, Yuji; Shundo, Atsuomi; Ohno, Masashi; Tsuruzoe, Nobutomo; Goto, Masahiro; Tanaka, Keiji

    2017-10-18

    When a peptide amphiphile is dispersed in water, it self-assembles into a fibrous network, leading to a supramolecular hydrogel. When the gel is physically disrupted by shaking, it transforms into a sol state. After aging at room temperature for a while, it spontaneously returns to the gel state, called sol-gel transition. However, repeating the sol-gel transition often causes a change in the rheological properties of the gel. To gain a better understanding of the sol-gel transition and its reversibility, we herein examined the thermal motion of probe particles at different locations in a supramolecular hydrogel. The sol obtained by shaking the gel was heterogeneous in terms of the rheological properties and the extent decreased with increasing aging time. This time course of heterogeneity, or homogeneity, which corresponded to the sol-to-gel transition, was observed for the 1st cycle. However, this was not the case for the 2nd and 3rd cycles; the heterogeneity was preserved even after aging. Fourier-transform infrared spectroscopy, small-angle X-ray scattering, and atomic force and confocal laser scanning microscopies revealed that, although the molecular aggregation states of amphiphiles both in the gel and sol remained unchanged with the cycles, the fibril density diversified to high and low density regions even after aging. The tracking of particles with different sizes indicated that the partial mesh size in the high density region and the characteristic length scale of the density fluctuation were smaller than 50 nm and 6 μm, respectively.

  10. Dermasence refining gel modulates pathogenetic factors of rosacea in vitro.

    PubMed

    Borelli, C; Becker, B; Thude, S; Fehrenbacher, B; Isermann, D

    2017-12-01

    Over the counter cosmetics sold for local treatment of slight to moderate rosacea often state the claim of actively modulating rosacea pathogenesis. Factors involved in the pathogenesis of this common yet complex skin disorder include kallikrein-related peptidase 5 (KLK5), LL-37, as well as protease-activated receptor 2 (PAR2) and vascular endothelial growth factor (VEGF). The objective was to prove the modulating effect of the cosmetic skin care agent Dermasence Refining Gel (DRG) on factors involved in rosacea pathogenesis. We analyzed the effect of DRG on the expression of KLK5, LL-37, PAR2, and VEGF in an in vitro skin model of human reconstituted epidermis. The expression of CAMP (LL-37 gene, fold change -4.19 [±0.11]), VEGFA (fold change -2.55 [±0.12]) and PAR2 (-1.33 [±0.12]) was reduced, KLK5 expression increased (fold change 2.06 (±0.08)) after 18 h of treatment with DRG in comparison to treatment with the matrix gel only. The reduction in CAMP expression was significant (P<.01). The protein expression of all four inflammatory markers was markedly reduced after 18 hours of DRG treatment in comparison to baseline (0 hour), by measure of fluorescence intensity. We show evidence explaining the anti-inflammatory effect of Dermasence Refining Gel in rosacea pathogenesis in vitro. The adjunctive use of DRG in mild to moderate rosacea as a topical cosmetic seems medically reasonable. © 2017 Wiley Periodicals, Inc.

  11. Meso-Decorated Switching-Knot Gels

    NASA Astrophysics Data System (ADS)

    Gong, Jin; Sawamura, Kensuke; Makino, Masato; Kabir, M. H.; Furukawa, Hidemitsu

    Gels are a new material having three-dimensional network structures of macromolecules. They possess excellent properties as swellability, high permeability and biocompatibility, and have been applied in various fields of daily life, food, medicine, architecture, and chemistry .In this study, we tried to prepare new multi-functional and high-strength gels by using Meso-Decoration (Meso-Deco), one new method of structure design at intermediate mesoscale. High-performance rigid-rod aromatic polymorphic crystals. The strengthening of gels can be realized by meso-decorating the gels' structure using high-performance polymorphic crystals. New gels with good mechanical properties, novel optical properties and thermal properties are expected to be developed.

  12. Compatibility between weak gel and microorganisms in weak gel-assisted microbial enhanced oil recovery.

    PubMed

    Qi, Yi-Bin; Zheng, Cheng-Gang; Lv, Cheng-Yuan; Lun, Zeng-Min; Ma, Tao

    2018-03-20

    To investigate weak gel-assisted microbial flooding in Block Wang Long Zhuang in the Jiangsu Oilfield, the compatibility of weak gel and microbe was evaluated using laboratory experiments. Bacillus sp. W5 was isolated from the formation water in Block Wang Long Zhuang. The rate of oil degradation reached 178 mg/day, and the rate of viscosity reduction reached 75.3%. Strain W5 could produce lipopeptide with a yield of 1254 mg/L. Emulsified crude oil was dispersed in the microbial degradation system, and the average diameter of the emulsified oil particles was 18.54 μm. Bacillus sp. W5 did not affect the rheological properties of the weak gel, and the presence of the weak gel did not significantly affect bacterial reproduction (as indicated by an unchanged microbial biomass), emulsification (surface tension is 35.56 mN/m and average oil particles size is 21.38 μm), oil degradation (162 mg/day) and oil viscosity reduction (72.7%). Core-flooding experiments indicated oil recovery of 23.6% when both weak gel and Bacillus sp. W5 were injected into the system, 14.76% when only the weak gel was injected, and 9.78% with strain W5 was injected without the weak gel. The results demonstrate good compatibility between strains W5 and the weak gel and highlight the application potential of weak gel-assisted microbial flooding. Copyright © 2018 The Society for Biotechnology, Japan. Published by Elsevier B.V. All rights reserved.

  13. Gels and gel-derived glasses in the system Na2O-B2O3-SiO2

    NASA Technical Reports Server (NTRS)

    Mukherjee, S. P.

    1983-01-01

    The containerless melting of high-purity multicomponent homogeneous gels and gel monoliths offers a unique approach to making ultrapure multicomponent optical glasses in the reduced gravity environment of space. Procedures for preparing and characterizing gels and gel-derived glasses in the system Na2O-B2O3-SiO2 are described. Preparation is based on the polymerization reactions of alkoxysilane with trimethyl borate or boric acid and a suitable sodium compound. The chemistry of the gelling process is discussed in terms of process parameters and the gel compositions. The physicochemical nature of gels prepared by three different procedures was found to be significantly different. Infrared absorption spectra indicate finite differences in the molecular structures of the different gels. The melting of the gel powders and the transformation of porous gel monoliths to transparent 'glass' without melting are described.

  14. Tretinoin Nanogel 0.025% Versus Conventional Gel 0.025% in Patients with Acne Vulgaris: A Randomized, Active Controlled, Multicentre, Parallel Group, Phase IV Clinical Trial

    PubMed Central

    Chandrashekhar, B S; Anitha, M.; Ruparelia, Mukesh; Vaidya, Pradyumna; Aamir, Riyaz; Shah, Sunil; Thilak, S; Aurangabadkar, Sanjeev; Pal, Sandeep; Saraswat, Abir

    2015-01-01

    Background: Conventional topical tretinoin formulation is often associated with local adverse events. Nanogel formulation of tretinoin has good physical stability and enables good penetration of tretinoin into the pilo-sebaceous glands. Aim: The present study was conducted to assess the efficacy and safety of a nanogel formulation of tretinoin as compared to its conventional gel formulation in the treatment of acne vulgaris of the face. Materials and Methods: This randomized, active controlled, multicentric, phase IV clinical trial evaluated the treatment of patients with acne vulgaris of the face by the two gel formulations locally applied once daily at night for 12 wk. Acne lesion counts (inflammatory, non-inflammatory & total) and severity grading were carried out on the monthly scheduled visits along with the tolerability assessments. Results: A total of 207 patients were randomized in the study. Reductions in the total (72.9% vs. 65.0%; p = 0.03) and inflammatory (78.1% vs. 66.9%; p = 0.02) acne lesions were reported to be significantly greater with the nanogel formulation as compared to the conventional gel formulation. Local adverse events were significantly less (p = 0.04) in the nanogel group (13.3%) as compared to the conventional gel group (24.7%). Dryness was the most common adverse event reported in both the treatment groups while peeling of skin, burning sensation and photosensitivity were reported in patients using the conventional gel only. Conclusion: In the treatment of acne vulgaris of the face, tretinoin nanogel formulation appears to be more effective and better tolerated than the conventional gel formulation. PMID:25738069

  15. Tissue simulating gel for medical research

    NASA Technical Reports Server (NTRS)

    Companion, John A. (Inventor)

    1989-01-01

    A tissue simulating gel and a method for preparing the tissue simulating gel are disclosed. The tissue simulating gel is prepared by a process using water, gelatin, ethylene gylcol, and a cross-linking agent. In order to closely approximate the characteristics of the type of tissue being simulated, other material has been added to change the electrical, sound conducting, and wave scattering properties of the tissue simulating gel. The result of the entire process is a formulation that will not melt at the elevated temperatures involved in hyperthermia medical research. Furthermore, the tissue simulating gel will not support mold or bacterial growth, is of a sufficient mechanical strength to maintain a desired shape without a supporting shell, and is non-hardening and non-drying. Substances were injected into the tissue simulating gel prior to the setting-up thereof just as they could be injected into actual tissue, and the tissue simulating gel is translucent so as to permit visual inspection of its interior. A polyurethane spray often used for coating circuit boards can be applied to the surface of the tissue simulating gel to give a texture similar to human skin, making the tissue simulating gel easier to handle and contributing to its longevity.

  16. Tissue simulating gel for medical research

    NASA Technical Reports Server (NTRS)

    Companion, John A. (Inventor)

    1991-01-01

    A tissue simulating gel and a method for preparing the tissue simulating gel are disclosed. The tissue simulating gel is prepared by a process using water, gelatin, ethylene glycol, and a cross-linking agent. In order to closely approximate the characteristics of the type of tissue being simulated, other material has been added to change the electrical, sound conducting, and wave scattering properties of the tissue simulating gel. The result of the entire process is a formulation that will not melt at the elevated temperatures involved in hyperthermia medical research. Furthermore, the tissue simulating gel will not support mold or bacterial growth, is of a sufficient mechanical strength to maintain a desired shape without a supporting shell, and is non-hardening and non-drying. Substances have been injected into the tissue simulating gel prior to the setting-up thereof just as they could be injected into actual tissue, and the tissue simulating gel is translucent so as to permit visual inspection of its interior. A polyurethane spray often used for coating circuit boards can be applied to the surface of the tissue simulating gel to give a texture similar to human skin, making the tissue simulating gel easier to handle and contributing to its longevity.

  17. The effect of a honey based gel and silver sulphadiazine on bacterial infections of in vitro burn wounds.

    PubMed

    Boekema, B K H L; Pool, L; Ulrich, M M W

    2013-06-01

    Bacterial contamination remains a constant threat in burn wound care. Topical treatments to combat contaminations have good bactericidal effects but can have detrimental effects for the healing process. Treatments with for example silver can increase healing times. Honey based products can be a good alternative as it is antibacterial and patient-friendly. We evaluated the bactericidal and cytotoxic effects of a honey based gel and silver sulphadiazine in a human burn wound model with Pseudomonas aeruginosa. After adding 10(5)colony forming units of P. aeruginosa, topical treatments were applied on the burn wound models. After 2, 12, 24, 28 and 70 h, bacteria were dislodged and counted by plating dilutions. Cytotoxic effects were evaluated histologically in samples of burn wound models treated topically for 3 weeks, without bacteria. L-Mesitran Soft significantly reduced the bacterial load (5-log reduction) up to 24h but did not completely eliminate bacteria from the burn wounds. After Flammazine(®) treatment, only a few colony forming units were observed at all time points. In contrast, re-epithelialization was significantly reduced after application of Flammazine(®) compared to L-Mesitran Soft or control. This in vitro model of burn wound infection can be used to evaluate topical treatments. L-Mesitran Soft is a good alternative for treating burn wounds but the slightly lower bactericidal activity in the burn wound model warrants a higher frequency of application. Copyright © 2012 Elsevier Ltd and ISBI. All rights reserved.

  18. Polyoxometalate-based Supramolecular Gel

    PubMed Central

    He, Peilei; Xu, Biao; Liu, Huiling; He, Su; Saleem, Faisal; Wang, Xun

    2013-01-01

    Self-assemblyings of surfactant-encapsulated Wells-Dawson polyoxometalates (SEPs) nanobuilding blocks in butanone and esters yielded supramolecular gels showing thermo and photo responsive properties. The gels can be further polymerized if unsaturated esters were used and subsequently electrospinned into nanowires and non-woven mats. The as-prepared non-woven mats have a Young's modulus as high as 542.55 MPa. It is believed that this supramolecular gel is a good platform for polyoxometalates processing. PMID:23666013

  19. Analysis of Zinc Oxide Thin Films Synthesized by Sol-Gel via Spin Coating

    NASA Astrophysics Data System (ADS)

    Wolgamott, Jon Carl

    Transparent conductive oxides are gaining an increasingly important role in optoelectronic devices such as solar cells. Doped zinc oxide is a candidate as a low cost and nontoxic alternative to tin doped indium oxide. Lab results have shown that both n-type and p-type zinc oxide can be created on a small scale. This can allow zinc oxide to be used as either an electrode as well as a buffer layer to increase efficiency and protect the active layer in solar cells. Sol-gel synthesis is emerging as a low temperature, low cost, and resource efficient alternative to producing transparent conducting oxides such as zinc oxide. For sol-gel derived zinc oxide thin films to reach their potential, research in this topic must continue to optimize the known processing parameters and expand to new parameters to tighten control and create novel processing techniques that improve performance. The processing parameters of drying and annealing temperatures as well as cooling rate were analyzed to see their effect on the structure of the prepared zinc oxide thin films. There were also preliminary tests done to modify the sol-gel process to include silver as a dopant to produce a p-type thin film. The results from this work show that the pre- and post- heating temperatures as well as the cooling rate all play their own unique role in the crystallization of the film. Results from silver doping show that more work needs to be done to create a sol-gel derived p-type zinc oxide thin film.

  20. Characteristics of platelet gels combined with silk

    PubMed Central

    Pallotta, Isabella; Kluge, Jonathan A.; Moreau, Jodie; Calabrese, Rossella

    2014-01-01

    Platelet gel, a fibrin network containing activated platelets, is widely used in regenerative medicine due the capacity of platelet-derived growth factors to accelerate and direct healing processes. However, limitations to this approach include poor mechanical properties, relatively rapid degradation, and the lack of control of release of growth factors at the site of injection. These issues compromise the ability of platelet gels for sustained function in regenerative medicine. In the present study, a combination of platelet gels with silk fibroin gel was studied to address the above limitations. Mixing sonicated silk gels with platelet gels extended the release of growth factors without inhibiting gel forming ability. The released growth factors were biologically active and their delivery was modified further by manipulation of the charge of the silk protein. Moreover, the silk gel augmented both the rheological properties and compressive stiffness of the platelet gel, tuned by the silk concentration and/or silk/platelet gel ratio. Silk-platelet gel injections in nude rats supported enhanced cell infiltration and blood vessel formation representing a step towards new platelet gel formulations with enhanced therapeutic impact. PMID:24480538

  1. Gel-expanded to gel-condensed transition in neurofilament networks revealed by direct force measurements

    NASA Astrophysics Data System (ADS)

    Beck, Roy; Deek, Joanna; Jones, Jayna B.; Safinya, Cyrus R.

    2010-01-01

    Neurofilaments (NF)-the principal cytoskeletal constituent of myelinated axons in vertebrates-consist of three molecular-weight subunit proteins NF-L (low), NF-M (medium) and NF-H (high), assembled to form mature filaments with protruding unstructured C-terminus side arms. Liquid-crystal gel networks of side-arm-mediated neurofilament assemblies have a key role in the mechanical stability of neuronal processes. Disruptions of the neurofilament network, owing to neurofilament over-accumulation or incorrect side-arm interactions, are a hallmark of motor-neuron diseases including amyotrophic lateral sclerosis. Using synchrotron X-ray scattering, we report on a direct measurement of forces in reconstituted neurofilament gels under osmotic pressure (P). With increasing pressure near physiological salt and average phosphorylation conditions, NF-LMH, comprising the three subunits near in vivo composition, or NF-LH gels, undergo for P>Pc~10kPa, an abrupt non-reversible gel-expanded to gel-condensed transition. The transition indicates side-arm-mediated attractions between neurofilaments consistent with an electrostatic model of interpenetrating chains. In contrast, NF-LM gels remain in a collapsed state for Pgel-condensed state at P>Pc. These findings, which delineate the distinct roles of NF-M and NF-H in regulating neurofilament interactions, shed light on possible mechanisms for disruptions of optimal mechanical network properties.

  2. Acceptability of a combination testosterone gel and depomedroxyprogesterone acetate male contraceptive regimen.

    PubMed

    Amory, John K; Page, Stephanie T; Anawalt, Bradley D; Matsumoto, Alvin M; Bremner, William J

    2007-03-01

    Testosterone (T) gel, administered transdermally in combination with injections of depomedroxyprogesterone acetate (DMPA) every 3 months, results in effective suppression of spermatogenesis in 90% of men. Men's attitudes regarding the daily self-administration of T-gel and the impact of such a regimen on sexual function, however, are unknown. Therefore, we questioned subjects enrolled in a combination T-gel plus DMPA male contraceptive trial regarding the acceptability of T-gel for male contraception and the impact of the T-gel/DMPA regimen on sexual function and satisfaction during treatment. Thirty-eight healthy men, ages 18-55, were treated with T-gel (100 mg daily) + DMPA (300 mg every 3 months) for 24 weeks. Sexual function was assessed using a validated questionnaire at baseline, after 12 and 24 weeks of treatment and 12 weeks into recovery. The overall acceptability of the method and attitudes regarding the daily self-administration of T-gel were assessed by a questionnaire 12 weeks into recovery. Fifty percent of subjects were either satisfied or very satisfied with the T-gel-based contraceptive regimen, and 45% indicated they would use the regimen if it were commercially available. The T-gel was found to be easy to use by 76% of men, but a third of subjects felt that T-gel administration interfered with their daily routine. Sexual function was largely preserved during treatment; however, slight decreases in sexual function were noted during recovery. The experimental male hormonal contraceptive regimen of T-gel + DMPA is acceptable to approximately one half of study volunteers, most of whom would use the method if it were commercially available. Given its appeal to a significant proportion of men, additional studies using T-gel and DMPA for male contraception are warranted.

  3. Clindamycin phosphate 1.2% and tretinoin 0.025% gel for rosacea: summary of a placebo-controlled, double-blind trial.

    PubMed

    Freeman, Scott A; Moon, Summer D; Spencer, James M

    2012-12-01

    Rosacea is a common, chronic, and poorly understood dermatological condition characterized by an inflammatory component composed of papules and pustules and a vascular component composed of flushing and erythema. Current treatment options include topical, systemic, and light-based methods, each of which focuses on either the inflammatory or the vascular component. Retinoids are not routinely indicated as treatment because of the common conception that they would be too inflammatory for the sensitive rosacea patient. However, photodamage may play a role in rosacea and tretinoin is well-known to repair photodamage. Thirty rosacea subjects were enrolled to assess their response to the use of clindamycin phosphate 1.2% and tretinoin 0.025% gel (ZIANA; Medicis Pharmaceutical Corporation, Scottsdale, AZ) for a period of 12 weeks. The results showed a dramatic decrease in pustules and papules without any significant inflammation or overall intolerance. No improvement in facial redness was achieved. Based on our results, more investigation of topical retinoids for rosacea treatment is prudent.

  4. Sol-gel optics for biomeasurements

    NASA Astrophysics Data System (ADS)

    Lechna-Marczynska, Monika I.; Podbielska, Halina; Ulatowska-Jarza, Agnieszka; Holowacz, Iwona; Andrzejewski, Damian

    2001-10-01

    Sol-gel technique is a method for producing of glass-like materials without involving a melting process. Organic compounds such as alcoholates of silicon, sodium or calcium can be used. The irregular non-crystalline network forms a gel structure where the metallic atoms are bonded to oxygen atoms. Low-temperature treatment turns this gel into an inorganic glass-like structure. There are numbers of applications of these materials that can be produced in various forms and shapes. Here, silica based sol-gel bulks and thin films optodes for biomedical applications will be presented.

  5. A heuristic approach to determine an appropriate number of topics in topic modeling

    PubMed Central

    2015-01-01

    Background Topic modelling is an active research field in machine learning. While mainly used to build models from unstructured textual data, it offers an effective means of data mining where samples represent documents, and different biological endpoints or omics data represent words. Latent Dirichlet Allocation (LDA) is the most commonly used topic modelling method across a wide number of technical fields. However, model development can be arduous and tedious, and requires burdensome and systematic sensitivity studies in order to find the best set of model parameters. Often, time-consuming subjective evaluations are needed to compare models. Currently, research has yielded no easy way to choose the proper number of topics in a model beyond a major iterative approach. Methods and results Based on analysis of variation of statistical perplexity during topic modelling, a heuristic approach is proposed in this study to estimate the most appropriate number of topics. Specifically, the rate of perplexity change (RPC) as a function of numbers of topics is proposed as a suitable selector. We test the stability and effectiveness of the proposed method for three markedly different types of grounded-truth datasets: Salmonella next generation sequencing, pharmacological side effects, and textual abstracts on computational biology and bioinformatics (TCBB) from PubMed. Conclusion The proposed RPC-based method is demonstrated to choose the best number of topics in three numerical experiments of widely different data types, and for databases of very different sizes. The work required was markedly less arduous than if full systematic sensitivity studies had been carried out with number of topics as a parameter. We understand that additional investigation is needed to substantiate the method's theoretical basis, and to establish its generalizability in terms of dataset characteristics. PMID:26424364

  6. Project Explorer's unique experiments: Get Away Special #007

    NASA Technical Reports Server (NTRS)

    Henderson, A. J., Jr.

    1986-01-01

    The Project Explorer payload represents the first attempt at broadcasting digitized voice signals via a Space Shuttle flight on amateur radio frequencies. These amateur ham-radio frequencies will be transmitting real time data while the experiments are operating. Experiments 1, 2, and 3 represent the work of students ranging from materials processing to the science of biology. Experiment 1 will study the solidification of two hypereutectic alloys, lead-antimony and aluminum-copper. Experiment 2 will investigate the examination and growth of radish seeds in space. Experiment 3 will examine the electrochemical growth process of potassium tetrocyonoplatinate hydrate crystals and Experiment 4 involves amateur radio transmissions, monitoring and support of the entire Get Away Special (GAS) 007 payload.

  7. Fractional carbon dioxide (CO2) laser combined with topical tretinoin for the treatment of different forms of cystic acne.

    PubMed

    Pestoni Porvén, Carmela; Vieira Dos Santos, Vanessa; Del Pozo Losada, Jesus

    2017-12-01

    Nodulocystic acne is prone to scarring and difficult to treat with treatments other than oral isotretinoin. The aim of this article is to discuss the role of a single session of a fractional carbon dioxide (CO 2 ) laser combined with a topical treatment with a tretinoin and antibiotic gel for a month as a successful treatment to improve nodulocystic acne and chronic microcystic acne. Two cases were involved: the first with nodulocystic acne lesions that persisted after oral retinoids and the second with chronic microcystic acne resistant to topical treatments. After only one session of treatment with the CO 2 laser and the topical treatment, a complete healing of the nodulocystic acne lesions was observed with minimal secondary effects. The microcystic acne showed great improvement. No other topical or oral treatment was needed. This treatment could be a safe and effective treatment for nodulocystic acne lesions and microcystic acne when other treatments fail. More studies should be performed to confirm our results.

  8. HierarchicalTopics: visually exploring large text collections using topic hierarchies.

    PubMed

    Dou, Wenwen; Yu, Li; Wang, Xiaoyu; Ma, Zhiqiang; Ribarsky, William

    2013-12-01

    Analyzing large textual collections has become increasingly challenging given the size of the data available and the rate that more data is being generated. Topic-based text summarization methods coupled with interactive visualizations have presented promising approaches to address the challenge of analyzing large text corpora. As the text corpora and vocabulary grow larger, more topics need to be generated in order to capture the meaningful latent themes and nuances in the corpora. However, it is difficult for most of current topic-based visualizations to represent large number of topics without being cluttered or illegible. To facilitate the representation and navigation of a large number of topics, we propose a visual analytics system--HierarchicalTopic (HT). HT integrates a computational algorithm, Topic Rose Tree, with an interactive visual interface. The Topic Rose Tree constructs a topic hierarchy based on a list of topics. The interactive visual interface is designed to present the topic content as well as temporal evolution of topics in a hierarchical fashion. User interactions are provided for users to make changes to the topic hierarchy based on their mental model of the topic space. To qualitatively evaluate HT, we present a case study that showcases how HierarchicalTopics aid expert users in making sense of a large number of topics and discovering interesting patterns of topic groups. We have also conducted a user study to quantitatively evaluate the effect of hierarchical topic structure. The study results reveal that the HT leads to faster identification of large number of relevant topics. We have also solicited user feedback during the experiments and incorporated some suggestions into the current version of HierarchicalTopics.

  9. Ocular biocompatibility of polyquaternium 10 gel: functional and morphological results.

    PubMed

    Alasino, Roxana Valeria; Garcia, Luciana Guadalupe; Gramajo, Ana Laura; Pusterla, Juan Pablo; Beltramo, Dante Miguel; Luna, José Domingo

    2015-02-01

    This paper deals with the characterization study of topical and intraocular biocompatibility and toxicity of cationic hydroxyethylcellulose Polyquaternium 10 (PQ10). It also evaluates the rheological properties of gels. The cytotoxicity assays were done in two cell lines: HEp-2 and VERO (human larynx epidermoid carcinoma cell and African green monkey kidney cells respectively). For the in vivo study, New Zealand albino rabbits were used. The in vitro cytotoxic activity of PQ10 shows no statistically significant differences in relation to the control of hydroxypropylmethylcellulose (HPMC) in any of the cell lines used in this study. Similarly, the signs of inflammation observed after treatment showed no significant difference between the groups of animals treated with the polymer compared to the control group. Normal histological characteristics were seen in both groups with no histological inflammatory reaction. After 1 month of the intracameral application of 2% PQ10 (treatment group) or 0.3% HPMC (control group), electroretinograms showed similar levels of a- and b-waves latencies and amplitude. In summary, PQ10 gel was well tolerated in these experiments, with proper monitoring, it could stand as a new alternative in the development of ophthalmic viscosurgical devices.

  10. Gel integration for microfluidic applications.

    PubMed

    Zhang, Xuanqi; Li, Lingjun; Luo, Chunxiong

    2016-05-21

    Molecular diffusive membranes or materials are important for biological applications in microfluidic systems. Hydrogels are typical materials that offer several advantages, such as free diffusion for small molecules, biocompatibility with most cells, temperature sensitivity, relatively low cost, and ease of production. With the development of microfluidic applications, hydrogels can be integrated into microfluidic systems by soft lithography, flow-solid processes or UV cure methods. Due to their special properties, hydrogels are widely used as fluid control modules, biochemical reaction modules or biological application modules in different applications. Although hydrogels have been used in microfluidic systems for more than ten years, many hydrogels' properties and integrated techniques have not been carefully elaborated. Here, we systematically review the physical properties of hydrogels, general methods for gel-microfluidics integration and applications of this field. Advanced topics and the outlook of hydrogel fabrication and applications are also discussed. We hope this review can help researchers choose suitable methods for their applications using hydrogels.

  11. Formulation of thermoresponsive and buccal adhesive in situ gel for treatment of oral thrush containing poorly water soluble drug bifonazole.

    PubMed

    Patel, Dimendra; Patel, Dipti; Prajapati, Jatin; Patel, Umang; Patel, Vijay

    2012-03-01

    The aim of the present work is to formulate and evaluate in situ oral topical gels of poorly water soluble drug Bifonazole based on temperature induced systems for the treatment of oral candidiasis. Bifonazole is poorly water soluble and low permeable drug means it's belongs to BCS Class IV. Due to its poor water solubility, it necessary to enhance solubility in water by make complex with Beta- Cyclodextrin (Drug to βCyclo Dextrine ratio is 1:1). After in situ gel preparation done by using Poloxamer (10% and 15%w/w) along with carbopol 934 (0.2 to 1.0% w/w) and Bifonazole - β CD complex (1%w/w). The formulations were evaluated for physiochemical parameter, gelation Temperature, viscosity, gel strength, content uniformity mucoadhesive force, Diffusion Study.

  12. Formulation of thermoresponsive and buccal adhesive in situ gel for treatment of oral thrush containing poorly water soluble drug bifonazole

    PubMed Central

    Patel, Dimendra; Patel, Dipti; Prajapati, Jatin; Patel, Umang; Patel, Vijay

    2012-01-01

    The aim of the present work is to formulate and evaluate in situ oral topical gels of poorly water soluble drug Bifonazole based on temperature induced systems for the treatment of oral candidiasis. Bifonazole is poorly water soluble and low permeable drug means it's belongs to BCS Class IV. Due to its poor water solubility, it necessary to enhance solubility in water by make complex with Beta- Cyclodextrin (Drug to βCyclo Dextrine ratio is 1:1). After in situ gel preparation done by using Poloxamer (10% and 15%w/w) along with carbopol 934 (0.2 to 1.0% w/w) and Bifonazole – β CD complex (1%w/w). The formulations were evaluated for physiochemical parameter, gelation Temperature, viscosity, gel strength, content uniformity mucoadhesive force, Diffusion Study. PMID:23066185

  13. Mechanical Failure in Colloidal Gels

    NASA Astrophysics Data System (ADS)

    Kodger, Thomas Edward

    When colloidal particles in a dispersion are made attractive, they aggregate into fractal clusters which grow to form a space-spanning network, or gel, even at low volume fractions. These gels are crucial to the rheological behavior of many personal care, food products and dispersion-based paints. The mechanical stability of these products relies on the stability of the colloidal gel network which acts as a scaffold to provide these products with desired mechanical properties and to prevent gravitational sedimentation of the dispersed components. Understanding the mechanical stability of such colloidal gels is thus of crucial importance to predict and control the properties of many soft solids. Once a colloidal gel forms, the heterogeneous structure bonded through weak physical interactions, is immediately subject to body forces, such as gravity, surface forces, such as adhesion to a container walls and shear forces; the interplay of these forces acting on the gel determines its stability. Even in the absence of external stresses, colloidal gels undergo internal rearrangements within the network that may cause the network structure to evolve gradually, in processes known as aging or coarsening or fail catastrophically, in a mechanical instability known as syneresis. Studying gel stability in the laboratory requires model colloidal system which may be tuned to eliminate these body or endogenous forces systematically. Using existing chemistry, I developed several systems to study delayed yielding by eliminating gravitational stresses through density matching and cyclic heating to induce attraction; and to study syneresis by eliminating adhesion to the container walls, altering the contact forces between colloids, and again, inducing gelation through heating. These results elucidate the varied yet concomitant mechanisms by which colloidal gels may locally or globally yield, but then reform due to the nature of the physical, or non-covalent, interactions which form

  14. Free forming of the gel by 3D gel printer SWIM-ER

    NASA Astrophysics Data System (ADS)

    Okada, Koji; Tase, Taishi; Saito, Azusa; Makino, Masato; Gong, Jin; Kawakami, Masaru; Furukawa, Hidemitsu

    2015-04-01

    Gels, soft and wet materials, have unique properties such as material permeability, biocompatibility and low friction, which are hardly found in hard and dry materials. These superior characteristics of hydrogels promise to expand the medical applications. In recent years, the optical 3D gel printer named SWIM-ER (Soft and Wet Industrial - Easy Realizer) was developed by our team in order to fabricate tough gels with free form. We are aiming to create artificial blood vessel of the gel material by 3D gel printer. Artificial blood vessel is expected to be used for vascular surgery practice. The artificial blood vessel made by 3D gel printer can be create to free form on the basis of the biological data of the patient. Therefore, we believe it is possible to contribute to increasing the success rate and safety of vascular surgery by creating artificial blood vessel with 3D gel printer. The modeling method of SWIM-ER is as follow. Pregel solution is polymerized by one-point UV irradiation with optical fiber. The irradiation area is controlled by computer program, so that exact 3D free forming is realized. In this study, synthesis conditions are re-examined in order to improve the degree of freedom of fabrication. The dimensional accuracy in height direction is improved by increasing the cross linker concentration. We examined the relationship of resolution to the pitch and UV irradiation time in order to improve the modeling accuracy.

  15. Apparatus and method for the production of gel beads containing a biocatalyst

    DOEpatents

    Scott, Charles D.; Scott, Timothy C.; Davison, Brian H.

    1998-01-01

    An apparatus and method for the large-scale and continuous production of gel beads containing a biocatalyst. The apparatus is a columnar system based on the chemical cross-linking of hydrocolloidal gels that contain and immobilize a biocatalyst, the biocatalyst being a microorganism or an enzyme. Hydrocolloidal gels, such as alginate, carrageenan, and a mixture of bone gelatin and modified alginate, provide immobilization matrices that can be used to entrap and retain the biocatalyst while allowing effective contact with substrates and release of products. Such immobilized biocatalysts are generally formulated into small spheres or beads that have high concentrations of the biocatalyst within the gel matrix. The columnar system includes a gel dispersion nozzle submerged in a heated non-interacting liquid, typically an organic liquid, that is immiscible with water to allow efficient formation of spherical gel droplets, the non-interacting liquid having a specific gravity that is less than water so that the gel droplets will fall through the liquid by the force of gravity. The heated non-interacting liquid is in direct contact with a chilled upflowing non-interacting liquid that will provide sufficient residence time for the gel droplets as they fall through the liquid so that they will be cooled below the gelling temperature and form solid spheres. The upflowing non-interacting liquid is in direct contact with an upflowing temperature-controlled aqueous solution containing the necessary chemicals for cross-linking or fixing of the gel beads to add the necessary stability. The flow rates of the two liquid streams can be varied to control the proper residence time in each liquid section to accommodate the production of gel beads of differing settling velocities. A valve is provided for continuous removal of the stabilized gel beads from the bottom of the column.

  16. Apparatus and method for the production of gel beads containing a biocatalyst

    DOEpatents

    Scott, C.D.; Scott, T.C.; Davison, B.H.

    1998-01-27

    An apparatus and method are disclosed for the large-scale and continuous production of gel beads containing a biocatalyst. The apparatus is a columnar system based on the chemical cross-linking of hydrocolloidal gels that contain and immobilize a biocatalyst, the biocatalyst being a microorganism or an enzyme. Hydrocolloidal gels, such as alginate, carrageenan, and a mixture of bone gelatin and modified alginate, provide immobilization matrices that can be used to entrap and retain the biocatalyst while allowing effective contact with substrates and release of products. Such immobilized biocatalysts are generally formulated into small spheres or beads that have high concentrations of the biocatalyst within the gel matrix. The columnar system includes a gel dispersion nozzle submerged in a heated non-interacting liquid, typically an organic liquid, that is immiscible with water to allow efficient formation of spherical gel droplets, the non-interacting liquid having a specific gravity that is less than water so that the gel droplets will fall through the liquid by the force of gravity. The heated non-interacting liquid is in direct contact with a chilled upflowing non-interacting liquid that will provide sufficient residence time for the gel droplets as they fall through the liquid so that they will be cooled below the gelling temperature and form solid spheres. The upflowing non-interacting liquid is in direct contact with an upflowing temperature-controlled aqueous solution containing the necessary chemicals for cross-linking or fixing of the gel beads to add the necessary stability. The flow rates of the two liquid streams can be varied to control the proper residence time in each liquid section to accommodate the production of gel beads of differing settling velocities. A valve is provided for continuous removal of the stabilized gel beads from the bottom of the column. 1 fig.

  17. Topical nanoparticulate formulation of drugs for ocular keratitis

    NASA Astrophysics Data System (ADS)

    Yang, Xiaoyan

    The primary objective of this project is to develop drug-loaded polymeric nanoparticles suspended in a biocompatible gel for topical delivery of therapeutic agents commonly employed in the treatment of ocular viral/bacterial keratitis. PART 1: Poly(D,L-lactic-co-glycolic acid) (PLGA) nanoparticles (NP) of dipeptide monoester prodrugs of ganciclovir (GCV) including L-Val-L-Val-GCV (LLGCV), L-Val-D-Val-GCV (LDGCV), D-Val-L-Val-GCV (DLGCV) were formulated and dispersed in thermosensitive PLGA-PEG-PLGA polymer gel for the treatment of herpes simplex virus type 1 (HSV-1) induced viral corneal keratitis. NP containing prodrugs of GCV were prepared by a double-emulsion solvent evaporation technique using various PLGA polymers with different drug/polymer ratios. Cytotoxicity studies suggested that all NP formulations are non-toxic. In vitro release of prodrugs from NP showed a biphasic release pattern with an initial burst phase followed by a sustained phase. Such burst effect was completely eliminated when NP were suspended in thermosensitive gels with near zero-order release kinetics. Prodrugs-loaded PLGA NP dispersed in thermosensitive gels can thus serve as a promising drug delivery system for the treatment of anterior eye diseases. Maximum uptake (around 60%) was noted at 3 h for NP. Cellular uptake and intracellular accumulation of prodrugs are significantly different among three stereoisomeric dipeptide prodrugs. The microscopic images show that NP are avidly internalized by HCEC cells and distributed throughout the cytoplasm instead of being localized on the cell surface. Following cellular uptake, prodrugs released from NP gradually bioreversed into parent drug GCV. LLGCV showed the highest degradation rate, followed by LDGCV and DLGCV. LLGCV, LDGCV and DLGCV released from NP exhibited superior uptake and bioreversion in corneal cells. PART 2: PLGA NP of hydrocortisone butyrate (HB) suspended in thermosensitive PLGA-PEG-PLGA gel were developed for the treatment of

  18. Cholesteric liquid crystal gels with a graded mechanical stress

    NASA Astrophysics Data System (ADS)

    Agez, Gonzague; Relaix, Sabrina; Mitov, Michel

    2014-02-01

    In cholesteric liquid-crystalline gels, the mechanical role of the polymer network over the structure of the whole gel has been ignored. We show that it is the stress gradient exerted by the network over the helical structure that drives the broadening of the optical band gap, as evidenced by the absence of a gradient in chiral species. Model calculations and finite-difference time-domain simulations show that the network acts as a spring with a stiffness gradient. The present results indicate a revision to the common understanding of the physical properties of liquid-crystalline gels is necessary when a concentration gradient in a polymer network is present.

  19. Cholesteric liquid crystal gels with a graded mechanical stress.

    PubMed

    Agez, Gonzague; Relaix, Sabrina; Mitov, Michel

    2014-02-01

    In cholesteric liquid-crystalline gels, the mechanical role of the polymer network over the structure of the whole gel has been ignored. We show that it is the stress gradient exerted by the network over the helical structure that drives the broadening of the optical band gap, as evidenced by the absence of a gradient in chiral species. Model calculations and finite-difference time-domain simulations show that the network acts as a spring with a stiffness gradient. The present results indicate a revision to the common understanding of the physical properties of liquid-crystalline gels is necessary when a concentration gradient in a polymer network is present.

  20. Posing for a picture: vesicle immobilization in agarose gel

    NASA Astrophysics Data System (ADS)

    Lira, Rafael B.; Steinkühler, Jan; Knorr, Roland L.; Dimova, Rumiana; Riske, Karin A.

    2016-05-01

    Taking a photo typically requires the object of interest to stand still. In science, imaging is potentiated by optical and electron microscopy. However, living and soft matter are not still. Thus, biological preparations for microscopy usually include a fixation step. Similarly, immobilization strategies are required for or substantially facilitate imaging of cells or lipid vesicles, and even more so for acquiring high-quality data via fluorescence-based techniques. Here, we describe a simple yet efficient method to immobilize objects such as lipid vesicles with sizes between 0.1 and 100 μm using agarose gel. We show that while large and giant unilamellar vesicles (LUVs and GUVs) can be caged in the pockets of the gel meshwork, small molecules, proteins and micelles remain free to diffuse through the gel and interact with membranes as in agarose-free solutions, and complex biochemical reactions involving several proteins can proceed in the gel. At the same time, immobilization in agarose has no adverse effect on the GUV size and stability. By applying techniques such as FRAP and FCS, we show that the lateral diffusion of lipids is not affected by the gel. Finally, our immobilization strategy allows capturing high-resolution 3D images of GUVs.